[Federal Register Volume 74, Number 153 (Tuesday, August 11, 2009)]
[Notices]
[Pages 40211-40212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19107]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0335]


Review of Post-Inspection Responses

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a program 
to support public health protection by facilitating the timely issuance 
of warning letters. The program establishes a timeframe for the 
submission and agency review of post-inspection responses to 
inspectional

[[Page 40212]]

observations that are communicated to a firm through issuance of a form 
FDA 483, list of inspectional observations.

DATES: The program will begin on September 15, 2009.

FOR FURTHER INFORMATION CONTACT:  Karen Stutsman, Division of 
Compliance Policy (HFC-230), Office of Enforcement, Office of 
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 240-632-6860.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA issues a form FDA 483, Inspectional Observations, upon 
completion of an inspection, to notify an inspected establishment's top 
management of objectionable conditions relating to products and/or 
processes, or other violations of the Federal Food, Drug, and Cosmetic 
Act and related acts, that were observed during the inspection.
    The FDA 483 form includes this preprinted instruction: ``This 
document lists observations made by the FDA representative(s) during 
the inspection of your facility. They are inspectional observations; 
and do not represent a final agency determination regarding your 
compliance. If you have an objection regarding an observation, or have 
implemented, or plan to implement corrective action in response to an 
observation, you may discuss the objection or action with the FDA 
representative(s) during the inspection or submit this information to 
FDA at the address [on the form].''
    When FDA determines, based on the inspection, that the 
establishment is in violation of the Federal Food, Drug, and Cosmetic 
Act or another statute that we enforce, we may issue a warning letter. 
Warning letters are issued only for significant violations that may 
lead to enforcement action if they are not promptly and adequately 
corrected. The decision to issue a warning letter is made by senior 
officials within FDA, often including the product center, after a 
thorough review of all of the relevant facts.
    It is not uncommon for an inspected establishment to respond in 
writing to observations made on an FDA 483 to describe completed or 
ongoing corrective actions or to promise future corrections. In fact, 
some inspected establishments submit multiple responses to FDA, 
sometimes over many months. Delayed and multiple responses to an FDA 
483 have resulted in delays in the issuance of warning letters while 
these responses are reviewed and addressed. FDA's timely issuance of a 
warning letter should help to achieve prompt voluntary compliance and 
is therefore in the public interest.
    While FDA considers corrective actions, and other factors, in 
determining whether to issue a warning letter, ongoing or promised 
corrective actions generally do not preclude the issuance of a warning 
letter. A warning letter is an important means of notifying regulated 
industry of violations and achieving prompt voluntary correction. 
Warning letters serve to ensure that the seriousness and scope of the 
violations are understood by top management of the inspected 
establishment, and that the appropriate resources are allocated to 
fully correct the violations and to prevent their recurrence. FDA is 
initiating a program to establish a timeframe for the submission of 
such post-inspection responses to FDA 483 inspectional observations for 
FDA's consideration in deciding whether to issue a warning letter. 
Under the program (described in more detail later in this document), 
the agency will not ordinarily delay the issuance of a warning letter 
in order to review a response to an FDA 483 that is received more than 
15 business days after the FDA 483 was issued.
    The purpose of this program is to optimize resource utilization, 
facilitate the timely issuance of warning letters, and promote prompt 
correction of violations. FDA will use the information from the program 
to determine whether to make the program permanent. FDA will conduct an 
assessment of the program after approximately 18 months.

II. Program Description

    Under the program, before issuing a warning letter, FDA will 
generally allow firms 15 business days to provide a response to FDA 483 
observations. If we receive a response to FDA 483 observations within 
15 business days after the FDA 483 was issued, we plan to conduct a 
detailed review of the response before determining whether to issue a 
warning letter. If we issue a warning letter after reviewing a firm's 
timely response, the warning letter will recognize receipt of the 
response and reply as to the apparent adequacy of the firm's corrective 
actions set forth in the response. Additional correspondence from FDA 
may be issued with regard to the response, if needed.
    If we receive a response to FDA 483 observations more than 15 
business days after the FDA 483 was issued, we do not plan to routinely 
include a response on the apparent adequacy of the firm's corrective 
actions in the warning letter. Rather, we plan to evaluate the response 
along with any other written material provided as the direct response 
to the warning letter (a firm's response to a warning letter may 
reference any of the firm's earlier responses).
    Note that FDA, at its discretion, may issue Warning Letters at any 
time, independent of receiving a response; and that firms are expected 
to implement needed corrections to conform to the requirements of the 
Federal Food, Drug, and Cosmetic Act and associated regulations 
regardless of whether they respond in writing to FDA or whether such a 
response is reviewed by FDA.
    After the 18-month time period, FDA will evaluate this program and 
decide whether to continue it with or without adjustments.

    Dated: August 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19107 Filed 8-10-09; 8:45 am]
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