Post-Warning Letter 
Meetings Under 
GDUFA 
Guidance for Industry 
 
 
 
 
 
 
DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 60 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit electronic comments to https://www.regulations.gov.  Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD  20852.  All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact (CDER) at 301-796-3400.  
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Office of Regulatory Affairs (ORA) 
 
 
September 2023 
Generic Drugs 
  Post-Warning Letter 
Meetings Under 
GDUFA 
Guidance for Industry 
 
 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs  
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Office of Regulatory Affairs (ORA) 
 
 
September 2023 
Generic Drugs 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  GDUFA III PERFORMANCE GOALS ......................................................................... 3 
IV.  POST-WARNING LETTER MEETINGS ..................................................................... 3 
V.  ELIGIBILITY CRITERIA .............................................................................................. 4 
VI.  MEETING REQUESTS FOR POST-WARNING LETTER MEETINGS ................. 4 
A.  Preparing the Meeting Package .................................................................................................... 5 
B.  Meeting Package Content .............................................................................................................. 6 
VII.  ASSESSING MEETING REQUESTS ............................................................................ 8 
A.  Meeting Request Granted ............................................................................................................. 8 
B.  Meeting Request Denied ................................................................................................................ 9 
C.  Meeting Request Deferred ............................................................................................................ 9 
VIII.  RESCHEDULING AND CANCELING POST-WARNING LETTER MEETINGS 9 
A.  Rescheduled Meetings ................................................................................................................... 9 
B.  Canceled Meetings ....................................................................................................................... 10 
IX.  PROCEDURES FOR CONDUCT OF MEETINGS ................................................... 10 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Post-Warning Letter Meetings Under GDUFA 
1 
Guidance for Industry1
2   
3   
4  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
5  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
6  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
7  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
8  for this guidance as listed on the title page.   
9   
10   
11   
12   
13  I.  INTRODUCTION  
14   
15  This guidance1 provides information on the implementation of the Post-Warning Letter Meeting 
16  process for certain facilities,2 a program enhancement agreed upon by the Agency and industry 
17  as part of the negotiations relating to the reauthorization of the Generic Drug User Fee 
18  Amendments (GDUFA), as described in the GDUFA Reauthorization Performance Goals and 
19  Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter).3  A Post-
20  Warning Letter Meeting, as described in section VII(D)(1) of the GDUFA III commitment letter, 
21  is a meeting with FDA regarding the facilitys remediation of deficiencies identified in a warning 
22  letter.4  This guidance specifically describes the process in the GDUFA III commitment letter5 
23  for how an eligible facility may request a Post-Warning Letter Meeting with FDA regarding the 
24  facilitys ongoing remediation efforts to current good manufacturing practice (CGMP) 
25  deficiencies6 described in a warning letter, how to prepare and submit a complete meeting 
26  request package, and how FDA intends to conduct the Post-Warning Letter Meeting.  
 
1 This guidance has been prepared by the Office of Compliance (OC) in the Center for Drug Evaluation and 
Research (CDER) in cooperation with the Office of Pharmaceutical Quality in CDER and Office of Regulatory 
Affairs (ORA) at the Food and Drug Administration.  In preparing this guidance, OC has also consulted with the 
Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH) and 
the Office of Combination Products (OCP).  
2 In this guidance, a facility is as defined in section 744A(6)(A) of the FD&C Act, i.e., a business or other entity 
under one management at one geographic location or address engaged in manufacturing or processing an active 
pharmaceutical ingredient or a finished dosage form of a drug (other than entities whose only manufacturing or 
processing activities are repackaging, relabeling, or testing).   
3 The GDUFA III commitment letter is available at https://www.fda.gov/media/153631/download. 
4 When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer, 
often in the form of a Warning Letter.  The Warning Letter identifies the violation, such as poor manufacturing 
practices, problems with claims for what a product can do, or incorrect directions for use.  The letter also makes 
clear that the company must correct the problem and provides directions and a timeframe for the company to inform 
FDA of its plans for correction.  See About Warning and Close-out Letters on FDAs website; also see section 4-1 
(Warning Letters) of the FDAs Regulatory Procedures Manual (June 2022). 
5 See section VII(D) of the GDUFA III commitment letter. 
6 For the purposes of this guidance, the term deficiencies is used interchangeably with deviations and violations, in 
referring to a specific failure of a facility producing a drug (e.g., active ingredient) to comply with current good 
manufacturing practice (CGMP) requirements under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)), including as detailed under 21 CFR parts 210 and 211).   
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
27   
28  In the GDUFA III commitment letter, FDA agreed to establish a Post-Warning Letter Meeting 
29  process for facilities to obtain preliminary feedback from FDA on the adequacy and 
30  completeness of corrective action and preventive action (CAPA)7,8 plans, to resolve the 
31  inspectional deficiencies identified in the warning letter.  Consistent with the commitment letter, 
32  the FDA intends to grant a meeting request only if the facility meets the criteria discussed below 
33  and has submitted to FDA a thorough and complete CAPA plan that addresses all items cited in 
34  the warning letter, and reasonable progress has been made toward remediation.9  
35   
36  Application-related discussions are not appropriate for Post-Warning Letter Meetings, even if 
37  FDA application assessors attend the meeting.10  This guidance also does not address requests for 
38  re-inspections as described in the commitment letter.11 
39   
40  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
41  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
42  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
43  the word should in Agency guidances means that something is suggested or recommended, but 
44  not required.  
45   
46   
47  II.  BACKGROUND 
48   
49  The Generic Drug User Fee Amendments of 2012 (GDUFA I)12 amended the Federal Food, 
50  Drug, and Cosmetic Act (FD&C Act) to authorize FDA to assess and collect user fees to provide 
51  FDA with additional resources to help ensure patients have access to quality, affordable, safe, 
52  and effective generic drugs.  GDUFA fee resources13 bring greater predictability and timeliness 
53  to the review of generic drug applications.  GDUFA has been reauthorized every five years to 
54  continue FDAs ability to assess and collect GDUFA fees, and this user fee program has been 
55  reauthorized two times since GDUFA I, most recently in the Generic Drug User Fee 
 
7 For more information on CAPAs, see FDAs guidance for industry Q10 Pharmaceutical Quality System (April 
2009).  We update guidances periodically.  For the most recent version of a guidance, check the FDA guidance web 
page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 
8 If a warning letter includes violations of 21 CFR part 4 for drug-device combination products (e.g., violations 
related to 21 CFR 820), the FDA organization chairing the Post-Warning Letter Meeting will consult CDRH subject 
matter experts. 
9 See section VII(D)(4) of the GDUFA III commitment letter. 
10 Requirements for communication between FDA and applicants are described in 21 CFR 314.102.  FDA provides 
recommendations on how applicants may amend or supplement an ANDA submission with facility changes in 
guidance for industry ANDA SubmissionsAmendments to Abbreviated New Drug Applications Under GDUFA 
(July 2018) and guidance for industry ANDA SubmissionsPrior Approval Supplements Under GDUFA (October 
2022). 
11 For more information regarding requesting re-inspection, see section VII(E) of the GDUFA III commitment letter, 
Generic Drug Manufacturing Facility Re-inspection.  A facility that meets the criteria described in section VII(E)(2) 
of the GDUFA III commitment letter may request a re-inspection under the terms of the commitment letter. 
12 Title III of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144. 
13 User fees are available for obligation in accordance with appropriations acts.  
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
56  Amendments of 2022.14 As described in the GDUFA III commitment letter applicable to this 
57  latest reauthorization, FDA has agreed to performance goals and program enhancements 
58  regarding aspects of the generic drug assessment program that build on previous authorizations 
59  of GDUFA. New enhancements to the program are designed to maximize the efficiency and 
60  utility of each assessment cycle, with the intent of reducing the number of assessment cycles for 
61  abbreviated new drug applications (ANDAs) and facilitating timely access to generic medicines 
62  for American patients.  
63   
64   
65  III.  GDUFA III PERFORMANCE GOALS  
66   
67  As indicated in section VII(D)(10) of the GDUFA III commitment letter, FDA committed to 
68  certain performance goals associated with Post-Warning Letter Meetings as described in this 
69  guidance.  The goals described below apply to Post-Warning Letter Meetings under GDUFA 
70  III15 (i.e., requests submitted on or after October 1, 2022, and subject to criteria described in this 
71  guidance). 
72   
73  FDA has committed to the following goals as they apply to FDAs decision regarding a Post-
74  Warning Letter Meeting request (i.e., to grant, deny, or defer in favor of re-inspection): 
75   
76    In FY 2024, 50 percent of eligible requests within 30 days of request. 
77    In FY 2025, 70 percent of eligible requests within 30 days of request. 
78    In FY 2026 and FY 2027, 80 percent of eligible requests within 30 days of request. 
79   
80  Section VII(D)(12)(b) of the GDUFA III commitment letter notes that if more than 50 percent of 
81  first-time meeting requests are denied because FDA makes an assessment that the facility is not 
82  ready, FDA intends to take appropriate action to provide additional information on meeting 
83  requests, which could include updating this guidance to provide further information on how 
84  facilities can avoid issues that have commonly led to meeting requests being denied. 
85   
86   
87  IV.  POST-WARNING LETTER MEETINGS   
88   
89  Under the terms of the GDUFA III commitment letter, a Post-Warning Letter Meeting will 
90  generally take place 6 months or later after the facility submits an initial response to the FDA 
91  warning letter.16  A facility may request that the meeting take place prior to 6 months after an 
92  initial response to a warning letter has been submitted.17  FDA may opt to grant an earlier 
93  meeting if the Agency determines it would be beneficial to both parties.  
94   
 
14 Enacted as Title III of Division F (the FDA User Fee Reauthorization Act of 2022) of the Continuing 
Appropriations and Ukraine Supplemental Appropriations Act, 2023 (Public Law 117-180). 
15 GDUFA III covers the period from October 1, 2022, through September 30, 2027. 
16 See section VII(D)(1) of the GDUFA III commitment letter. 
17 The request and scheduling of a Post-Warning Letter Meeting may affect the timing of FDAs follow-up 
inspectional activities should FDA choose to conduct a follow-up inspection after the meeting is held. 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
95  Holding a Post-Warning Letter Meeting does not preclude FDA regulatory actions (including 
96  prior to the Post-Warning Letter Meeting).  As with other meetings or written correspondence 
97  with a firm, FDA advice provided at a Post-Warning Letter Meeting is not binding on the 
98  Agency.  FDA maintains the ability to meet with firms on other topics outside GDUFA 
99  commitments.  
100   
101  FDA may opt to conduct the meetings by video conference, teleconference, or face-to-face, at 
102  FDAs discretion. 
103   
104   
105  V.  ELIGIBILITY CRITERIA 
106   
107  Under section VII(D)(3) of the GDUFA III commitment letter, FDA agreed that a facility is 
108  considered eligible to request a Post-Warning Letter Meeting if the facility meets the following 
109  criteria: 
110   
111  1.  The facility Current Good Manufacturing Practice (CGMP) compliance status is Official 
112  Action Indicated (OAI) as a result of an FDA inspection; 
113   
114  2.  The facility has paid a GDUFA facility fee as described in section 744B(a)(4) of the 
115  FD&C Act, for the current fiscal year, or is named in a pending ANDA application; and 
116   
117  3.  The regulatory action (e.g., warning letter) is limited only to violations and/or deviations 
118  from section 501 of the FD&C Act (21 U.S.C 351) related to human drug manufacturing, 
119  including the manufacturing of a drug-device combination product. 
120   
121   
122  VI.  MEETING REQUESTS FOR POST-WARNING LETTER MEETINGS 
123   
124  A complete meeting package to request a Post-Warning Letter Meeting should be submitted 
125  electronically18 and consist of the CAPA plan and any supplementary information that 
126  demonstrates that actions in progress are intended to assure systemic remediation of deficient 
127  practices at the facility.  The meeting package should contain sufficient detail to meet the 
128  intended meeting objectives.  
129   
130  FDA intends to only accept a Post-Warning Letter Meeting request from the facility, parent 
131  company, or authorized legal representative.  FDA does not intend to accept meeting requests 
 
18 FDA has established secure email at FDA-GDUFAIII-PostWarningLetterandReinspectionRequests@fda.hhs.gov 
for Post-Warning Letter Meeting and facility re-inspection requests, as described on the FDA GDUFA III  Changes 
for Facilities web page at https://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-changes-
facilities.  To ensure timely assignment of a goal date, requests should be sent to this mailbox.  Non-electronic 
requests, and request correspondence sent elsewhere in the Agency may delay assignment of a goal date.  FDA, at 
its discretion, may reroute requests that are sent elsewhere to the appropriate location. 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
132  from third parties, such as applicants (unless the applicant and the facility are the same legal 
133  entity) or customers of the facility.19 
134   
135  The meeting package should clearly indicate that the facility is requesting a Post-Warning Letter 
136  Meeting under the terms of the GDUFA III commitment letter and include adequate information 
137  for FDA to assess the potential utility of the meeting.  We anticipate that reasonable progress 
138  toward remediation is unlikely if a request for a Post-Warning Letter Meeting is filed in 
139  conjunction with or around the same time as when the firm submits its warning letter response 
140  (i.e., within 15 working days of the warning letter).  Therefore, the request for the meeting 
141  should be made in a separate and subsequent submission from the firms warning letter response.  
142  A facility should continue to submit warning letter responses and any subsequent updates to 
143  FDA as described in the warning letter. 
144   
145  A.  Preparing the Meeting Package 
146   
147  Pre-meeting preparation is critical for achieving a productive discussion at the Post-Warning 
148  Letter Meeting.  Preparing the meeting package should help the facility focus on describing its 
149  principal areas of interest.  The meeting package should show that the facility has made 
150  reasonable progress towards systemic remediation of the deviations and/or violations cited in the 
151  warning letter.  Providing specific information relevant to the discussion topics is essential for 
152  FDA to determine whether to grant or deny the meeting, and adequately prepare for the meeting 
153  if the request is granted.  
154   
155  As described in the FDAs Regulatory Procedures Manual, 20 a warning letter is the Agency's 
156  principal means of achieving prompt voluntary compliance.  While a warning letter notifies a 
157  responsible facility that the Agency considers one or more products, practices, processes, or 
158  other activities to be in violation of FD&C Act, its implementing regulations, and other federal 
159  statutes, the deviations and/or violations cited in a warning letter are not intended to be an all-
160  inclusive list of deviations or violations that exist in the facility.  As generally explained in 
161  warning letters, the firm is responsible for investigating and determining the causes of any 
162  deviations and/or violations (including observations listed on the Form FDA 483 and any verbal 
163  observations communicated with the firm during the inspection), to prevent their recurrence or 
164  the occurrence of other violations.21  To facilitate resolution of CGMP deviations that resulted in 
165  an unacceptable compliance status for the facility (i.e., OAI status), the Post-Warning Letter 
166  Meeting may include discussion of remediation activities for all deviations identified during the 
167  inspection, whether or not those issues were included in the warning letter.  
168   
169  For each deviation and/or violation described in the warning letter, the meeting package should 
170  include a description of the root cause analysis and a retrospective evaluation of the impact of 
171  each deficiency on product quality and other systems at the same facility and systems at different 
 
19 FDA recommends facility representatives who attend the Post-Warning Letter Meeting be those knowledgeable 
about the CGMP remediation activities described in the meeting package.  This will help the facility accurately 
communicate the remediation activities to FDA, provide complete responses to FDAs follow-up questions, and 
remain focused on the CAPA plan.   
20 See section 4-1 (Warning Letters) of the FDAs Regulatory Procedures Manual (June 2022).  
21 Id. 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
172  facilities22 (e.g., operational design, quality system flaws) for all planned or implemented CAPAs 
173  as well as a CAPA plan timeline.  The meeting package should include a reference to each 
174  warning letter response and supporting documentation.  
175   
176  B.  Meeting Package Content  
177   
178  To facilitate FDA review, the meeting package content should be concise and organized 
179  according to the proposed agenda.  The meeting package should be a sequentially paginated 
180  document (individual sections can be numbered separately, but there should be an overall 
181  pagination for the whole submission) with a table of contents, appropriate indices, appendices, 
182  cross-references, and bookmarks differentiating sections.  Complete meeting packages should 
183  generally include the following information and concise responses to each violation or deviation 
184  (not including summary table or supporting documentation):23 
185   
186  Facility information 
187   
188  1.  Establishment name and facility address. 
189   
190  2.  FDA Establishment Identification (FEI) Number. 
191   
192  3.  Warning Letter number or CMS case number. 
193   
194  4.  Indicate whether this is the initial or second request for a Post-Warning Letter Meeting. 
195   
196  5.  Indicate whether the GDUFA facility fee24 has been paid for the current year or if the 
197  facility is listed only in pending ANDA(s). 
198   
199  Meeting Logistics 
200   
201  1.  A list of all individuals, with their titles and affiliations, who will attend the meeting from 
202  the facilitys organization, including consultants and interpreters. 
203   
204  a.  Include signed Letters of Authorization or Representation for any meeting attendees 
205  not directly affiliated with the facility, parent company, or authorized legal 
206  representative. 
207   
 
22 Meaning systems at different facilities owned or operated by the entity to which the warning letter is addressed 
and to which the CGMP violations cited in the warning letter are also applicable. 
23 Under the GDUFA III commitment letter, any supplemental information submitted by the facility on remediation 
progress to be discussed at the meeting is to be submitted to FDA at least 60 days prior to the meeting (see section 
VII(D)(5) of the GDUFA III commitment letter).  
24 See section 744B(a)(4) of the FD&C Act.  Note: some facilities are exempt from the requirement to pay a 
GDUFA facility fee (e.g., positron emission tomography drug producers, facilities only listed in applications 
submitted by State and/or Federal government entities for drugs not distributed commercially).  See section VIII(B) 
of FDAs guidance for industry Assessing User Fees Under the Generic Drug User Fee Amendments of 2022. 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
208  2.  If the firm is requesting specific dates, the meeting package should include suggested 
209  date ranges and times (e.g., morning or afternoon).  As noted in section IV above, a Post-
210  Warning Letter Meeting will generally take place 6 months or later after the facility 
211  submits an initial response to the FDA warning letter. 
212   
213  3.  Nonavailability dates and times should also be included. 
214   
215   
216  4.  The proposed format of the meeting (i.e., face-to-face, video conference, or 
217  teleconference). 
218   
219  5.  A proposed meeting agenda, including estimated times needed for discussing each 
220  agenda item (Note: meetings are generally 1 hour in length). 
221   
222  CAPA Summary, Status Report, and Questions 
223   
224  1.  A section and/or table(s) (see example below) that include the following: 
225   
226  a.  List of CAPAs in the order corresponding to the violation or deviation listed in the 
227  warning letter.25 Note: if the package is referencing prior responses to the warning 
228  letter, include the date and page number of the warning letter response that describes 
229  the remediation and the associated supporting documentation. 
230   
231  b.  A summary of whether other systems at the same facility or systems at a different 
232  facility owned or operated by the firm are affected by the corresponding violation or 
233  deviation. 
234   
235  c.  Timeframes for CAPAs, including interim actions.26 
236   
237  d.  Summary of all CAPAs opened for violations or deviations cited in the warning letter, 
238  identifying whether the CAPA is resolved or in-progress, and percent-complete. 
239   
240  e.  Summary of any additional CAPAs not related to issues specifically cited in the 
241  warning letter but nonetheless related to the associated inspection and resulting FDA 
242  Form 483.  Note: if previous or post-warning letter inspections are also classified as 
243  OAI, a summary of those CAPAs and completion status should be included as well. 
244   
 
25 To provide a systemic response to violations or deviations, the warning letter should be fully reviewed to ensure 
that responses incorporate other pertinent feedback provided by FDA in the letter (e.g., overarching feedback 
provided at the conclusion of the letter regarding management oversight, ineffective systems, data integrity 
remediation).  If this information has been provided previously, we recommend utilizing a consistent numbering 
scheme. 
26 Longer timeframes for CAPA activities such as building a new, higher capability facility may be needed in some 
cases with the intent to ensure durable solutions.  In such cases, depending on the nature and extent of violations at a 
facility, a longer CAPA timeframe accompanied by an interim solution may be preferable if FDA determines that 
quality and compliance will clearly benefit. 
  7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
245  2.  A list of key questions that can be reasonably discussed within the scheduled meeting 
246  time.  
247   
248  FDA recommends the use of tables to organize the information in the meeting package.  Meeting 
249  packages should contain a table organized by warning letter item number, Form FDA 483 
250  deviation number, and a description of the other CAPAs created to ensure systemic CGMP 
251  compliance.  Below is an example of key elements to address and how a facility may choose to 
252  organize the information. 
253   
FDA 483 Deviation 
number, WL item 
number, or additional  Topic/System  Summary  CAPA Number  Target Date  Current Progress 
CAPA item (brief 
descriptive name) 
Substantive summary of 
status, including: 1) to be 
Facility,  Brief summary  initiated; 2) in-progress; 
1, 1a, etc.  equipment,  of issue and  CAPA Number  Target Date  or 3) completed.  
etc.  CAPA  Describe any issues that 
may influence timing of 
completion  
254   
255   
256  VII.  ASSESSING MEETING REQUESTS  
257   
258  A facility requesting a Post-Warning Letter Meeting should submit a complete meeting package 
259  to FDA.  The Agency will then review the criteria under the GDUFA III commitment letter for 
260  granting a meeting request, and review the meeting request package content, as described in 
261  sections V and VI, respectively.  During review of the meeting package, FDA may request 
262  clarifying information.  After FDA has completed the review, the facility will be notified of the 
263  decision to grant, deny, or defer the Post-Warning Letter Meeting.  
264   
265  A.  Meeting Request Granted 
266   
267  FDA intends to grant a Post-Warning Letter Meeting request under the GDUFA III commitment 
268  letter only if the facility has submitted to FDA a thorough and complete CAPA plan that 
269  addresses all items cited in the warning letter, and reasonable progress has been made toward 
270  remediation.27   
271   
272  If FDA grants a request for a Post-Warning Letter Meeting, we intend to provide notification of 
273  the decision by email to the requesting facility.  FDA will then schedule the meeting and 
274  determine the date, time, length, place, and expected FDA participants.  All scheduling 
275  information will be forwarded to the facility following notification that the meeting request has 
276  been granted.  
277   
 
27 See section VII(D)(4) of the GDUFA III commitment letter. 
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278  B.  Meeting Request Denied 
279   
280  Under the terms of the GDUFA III commitment letter,28 FDA may deny a request for a Post-
281  Warning Letter Meeting if the facility: (1) fails to develop a thorough and complete CAPA plan 
282  that addresses all items cited in the warning letter; (2) does not include in the meeting package 
283  information or other documentation establishing that sufficient progress has been made toward 
284  remediation; (3) the meeting package is otherwise incomplete; or (4) the facility is not eligible as 
285  described in section V above.  For example, FDA may deny a request for a meeting if the CAPA 
286  does not include a retrospective evaluation of the scope of issues, address whether other systems 
287  or facilities are affected by the problem or include supporting documentation.  
288   
289  If FDA denies a request for a Post-Warning Letter Meeting, FDA generally intends to provide 
290  the facility written notification that includes an explanation of the reason(s) for the denial.29  
291  Under section VII(D)(7) of the GDUFA III commitment letter, a facility is allocated two requests 
292  for a Post-Warning Letter Meeting per warning letter.  Under section VII(D)(6)(b) of the 
293  GDUFA III commitment letter, a facility is to resubmit a new meeting request no sooner than 3 
294  months after the first meeting request is denied by the FDA.  FDA intends to consider this 
295  second submission requesting a Post-Warning Letter Meeting, after the first is denied, a second 
296  and final request.  
297   
298  C.  Meeting Request Deferred 
299   
300  As described in the GDUFA III commitment letter,30 FDA may opt to defer a Post-Warning 
301  Letter Meeting if FDA has determined that a re-inspection is the most appropriate next step (i.e., 
302  defer the meeting in favor of re-inspection).  In this case, FDA intends to notify the facility of the 
303  decision to re-inspect rather than grant a meeting.  
304   
305   
306  VIII.  RESCHEDULING AND CANCELING POST-WARNING LETTER MEETINGS 
307   
308  FDA will determine whether the meeting should be rescheduled or canceled, depending on the 
309  specific circumstances.  Facilities and FDA should take reasonable steps to avoid rescheduling 
310  and canceling meetings (unless the meeting is no longer necessary).  For example, if an attendee 
311  becomes unavailable, a substitute can be identified, or comments on the topic that the attendee 
312  would have addressed can be forwarded to the facility following the meeting. 
313   
314  A.  Rescheduled Meetings 
315   
316  If FDA determines that a Post-Warning Letter Meeting needs to be rescheduled, FDA intends to 
317  reschedule it as soon as possible after the original date.  A new meeting request should not be 
318  submitted.  A meeting may be rescheduled if, for example: 
319   
 
28 See sections VII(D)(4) and VII(D)(6) of the GDUFA III commitment letter. 
29 See section VII(D)(6)(a) of the GDUFA commitment letter.  
30 See section VII(D)(8) of the GDUFA III commitment letter. 
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320    The FDA determines that additional information is needed from the facility to address the 
321  facilitys meeting package questions. 
322   
323    Essential attendees are no longer available for the scheduled date and time because of an 
324  emergency. 
325   
326    Attendance by additional FDA offices, not originally anticipated or requested by the 
327  facility, is critical and the offices availability precludes holding the meeting on the 
328  original date. 
329   
330    There is a regulatory policy issue that is yet to be resolved that may affect the response to 
331  the facilitys questions. 
332   
333    The Federal government is closed, or opening is delayed due to inclement weather, 
334  emergency, or other reason. 
335   
336  If a facility requests that a Post-Warning Letter Meeting be rescheduled, FDA will make every 
337  effort to ensure the meeting occurs within a reasonable time.  
338   
339  B.  Canceled Meetings 
340   
341  If a Post-Warning Letter Meeting is canceled by a facility, FDA intends to consider a subsequent 
342  request to schedule another such meeting to be a second and final Post-Warning Letter Meeting 
343  request.  A Post-Warning Letter Meeting may be canceled if, for example: 
344   
345    The facility withdraws the meeting request. 
346   
347    The facility determines its questions have been adequately answered by any preliminary 
348  written comments from FDA. 
349   
350  FDA may opt to cancel the meeting because of its subsequent determination that a re-inspection 
351  is the most appropriate next step.  
352   
353   
354  IX.  PROCEDURES FOR CONDUCT OF MEETINGS 
355   
356  Post-Warning Letter Meetings will be chaired by FDA and will generally be scheduled for one 
357  hour.  To ensure a productive meeting, materials should be submitted to FDA 30 calendar days 
358  prior to the scheduled meeting date. Materials submitted after that date may not allow FDA 
359  sufficient time for consideration and thus preclude a productive meeting.  All presentations 
360  should be brief to maximize the time available for discussion.  FDA recommends the following 
361  format for Post-Warning Letter Meetings: 
362   
363    Introductions  
364   
365    FDA opening remarks 
  10  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
366   
367    Facility presentation of the CAPA plan progress and questions 
368   
369    FDA and facility discussion of the CAPA plan progress and facility questions (allowing 
370  for at least 30 minutes) 
371   
372    Action items and next steps 
373   
374    Closing remarks by corporate or facility senior leadership 
375   
376    FDA closing remarks and discussion of any action items 
377   
378  The facility may generate their own meeting minutes for their internal use.  FDA does not intend 
379  to accept or comment on firm-generated meeting minutes and does not intend to consider them 
380  an official reflection of meeting discussions.  Any FDA meeting notes of the meeting are 
381  considered internal Agency documents.  FDA does not intend to permit recording of these 
382  meetings without prior written FDA consent. 
383   
384  If you have any questions regarding your request, please contact FDA-GDUFAIII-
385  PostWarningLetterandReinspectionRequests@fda.hhs.gov. 
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