Contains Nonbinding Recommendations 
 
Guidance for Industry and FDA 
Staff 
Surveillance and Detention 
Without Physical Examination of 
Condoms 
 
Document issued on: July 11, 2008  
 
 
 
The draft of this document was issued on August 14, 2000 
 
For questions regarding this document contact J. Michael Kuchinski at 240-276-0115 or by 
email at J.Kuchinski@fda.hhs.gov. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
OB/GYN, Gastroenterology and Urology Devices Branch  
Division of Enforcement A 
Office of Compliance 
 
 
 
  Contains Nonbinding Recommendations 
 
 
Preface 
 
 
Public Comment 
 
 
Written comments and suggestions may be submitted at any time for Agency consideration to 
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, (HFA-305), Rockville, MD, 20852.  Alternatively, electronic comments may be 
submitted to http://www.regulations.gov.  When submitting comments, please refer to Docket 
No. 00D-1139.  Comments may not be acted upon by the Agency until the document is next 
revised or updated. 
 
 
Additional Copies 
 
 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/comp/guidance/1139.pdf.  You may also send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 
240-276-3151 to receive a hard copy.  Please use the document number 1139 to identify the 
guidance you are requesting.
 
 
      ii Contains Nonbinding Recommendations 
 
 
Guidance for Industry and FDA Staff 
 
Surveillance and Detention Without Physical 
Examination of Condoms 
 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on 
this topic.  It does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of this 
guidance.  
 
Introduction 
Consumers rely on condoms for protection from HIV (AIDS) and other sexually transmitted 
diseases (STDs), as well as for contraception.    Because condom defects, such as holes, can 
compromise the effectiveness of the condom barrier and pose a potentially significant hazard to 
the health of users, FDA samples condoms and performs water leak testing as described in 
Compliance Policy Guide CPG 7124.21.    
FDAs Center for Devices and Radiological Health (CDRH) is aware from its import records that 
some foreign manufacturers and shippers repeatedly attempt to import condoms that fail water 
leak testing (i.e., they do not meet the acceptable quality criteria defined in CPG 7124.21, based 
on the number of defective condoms in the samples). To address the issue, FDA proposed a 
strategy for import surveillance and detention in the draft guidance made available on August 14, 
2000.    FDA is making available this final guidance document to provide guidance to FDA staff 
and industry regarding FDAs strategy for addressing further imports of condoms from 
manufacturers/shippers1 whose condoms have failed to meet FDAs minimum acceptable quality 
criteria.   
                                                           
1 In this guidance, the terms "manufacturer"  and "shipper" refer to an entity whose name and address will be listed 
on the Import Alert  as part of the information to identify the condoms that are subject to detention without physical 
examination because of an appearance of adulteration.  As used in this guidance, the term "firm" refers to an entity 
      1 Contains Nonbinding Recommendations 
 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
The Least Burdensome Approach 
We believe we should consider the least burdensome approach in all areas of medical device 
regulation.  This guidance reflects our careful review of the relevant scientific and legal 
requirements and what we believe is the least burdensome way for you to comply with those 
requirements.  However, if you believe that an alternative approach would be less burdensome, 
please contact us so we can consider your point of view.  You may send your written comments to 
the contact person listed in the preface to this guidance or to the CDRH Ombudsman.  
Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be 
found on the Internet at http://www.fda.gov/cdrh/ombudsman/.  
Legal Basis for Denying Admission of Condoms  
FDA may refuse admission of condoms into the United States under section 801(a)(3) of the 
Federal Food, Drug, and Cosmetic Act (the Act) if it appears from examination that they are 
adulterated or misbranded (21 U.S.C. 381(a)(3)). 
FDA specifically defines sampling plans and adulteration criteria for condoms in Compliance 
Policy Guide CPG 7124.21.  If FDA determines that a sampled shipment of condoms contains an 
unacceptable level of defects as described in CPG 7124.21, then the shipment appear to be 
adulterated under section 501(c) of the Act (21 U.S.C. 351(c)), which defines a device as 
adulterated if its quality falls below that which it purports or is represented to possess.  
In addition, repeated shipments of adulterated condoms may present the appearance that the 
condoms are not manufactured in accordance with the Quality Systems regulation, Title 21, 
Code of Federal Regulations (CFR) Part 820, which is promulgated under section 520(f) of the 
Act.  When a device appears to be in nonconformance with section 520(f) of the Act, the devices 
may be refused admission to the United States not only under section 801(a)(3)of the Act (21 
U.S.C. 381(a)(3)), but also under section 801(a)(1) (21 U.S.C. 381(a)(1)), which authorizes 
refusal of admission, If it appears from the examination of such samples or otherwise that ... 
the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or 
 
installation of the device do not conform to the requirements of section 520(f). 
Surveillance and Placement on Import Alert #85-02  
FDA field offices may detain, without physical examination, all shipments of condoms from 
manufacturers/shippers listed on FDAs Import Alert #85-02, Attachments A and B. Surveillance 
                                                                                                                                                                                           
providing information to the agency to rebut the appearance of adulteration applicable to particular condoms.  This 
might be the manufacturer/shipper, importer, distributor or other entity.   
      2 Contains Nonbinding Recommendations 
 
 
sampling of condoms from manufacturers/shippers that do not appear on Attachments A and B 
of Import Alert #85-02 should be performed according to the latest import guidance. (For 
information regarding sampling, see the Sampling section of this document on page 10.) 
Because the presence of defects in condoms may present a potentially significant health hazard, 
one (1) violative sample may be sufficient to recommend detention without physical examination  
as described in Chapter 9, Section 6 of the  FDA Regulatory Procedures Manual 2008 (Import 
Operations and Actions; Detention without Physical Examination (DWPE)).   Therefore, in 
addition to detaining the violative shipment, the FDA field office at the port of entry should also 
submit a recommendation for detention of future shipments without physical examination to the 
Division of Import Operations and Policy (DIOP) at HFC-170.  
Condoms from identified manufacturers/shippers should be placed on Import Alert #85-02 under 
the regulatory classification category "condom" only. Specific types/styles of condoms, such as 
spermicidal, ribbed, contoured, etc., are not considered separate categories for the purposes of 
Import Alert #85-02 and should not be referenced in a recommendation for detention.  DIOP 
should review the recommendation to ensure the evidence supports detention without physical 
examination in accordance with the Act, and that such detention is consistent with the policy 
expressed in this guidance.  
While a manufacturer/shipper is listed on Import Alert #85-02, any subsequent shipments of 
condoms from the same manufacturer/shipper may be detained without physical examination, 
including types, styles, or brands of condoms that were not specifically found violative by 
testing. 
Purpose of Import Strategy 
This guidance provides a risk-based decision process for managing the Agencys available 
resources for condoms.  FDAs strategy will manage the large volume of condom imports while 
allowing adequate opportunities for firms to demonstrate that the condoms offered for import 
conform to FDAs acceptable quality criteria.  Accordingly, FDA has devised a risk-based, tiered 
process for placing condoms from identified manufacturer/shippers on Import Alert #85-02, for 
releasing individual shipments, and for removing condoms from the identified 
manufacturers/shippers from the import alert.  
Import Strategy 
This guidance document describes three levels of import surveillance and detention for condoms 
from manufacturers/shippers who have offered for import to the United States condoms that do 
not meet FDAs acceptable quality criteria that appear in CPG 7124.21, as evidenced by failure 
of FDA or independent private laboratory water leak testing occurring within a 
manufacturers/shippers Import Surveillance Cycle (Cycle).  A manufacturers/shippers Cycle 
begins on the date that it is placed on Level 1 Detention and ends when 24 months have elapsed 
since the initiation of the Cycle unless condoms from the manufacturers/shipper are placed on 
Level 3 detention, as described below in this guidance document.   
      3 Contains Nonbinding Recommendations 
 
 
For each level, the guidance explains the criteria for that level, the actions the agency may take 
regarding import detention and refusal of admission, and what the agency will accept as evidence 
to demonstrate that the condoms being offered for import meet FDAs minimum acceptable 
quality criteria.  
Determining the Import Detention Level 
Routine examination of imports of condoms is conducted in accordance with CPG 7124.21. 
When such an examination reveals that a shipment of condoms is defective, FDA's enforcement 
strategy for addressing that shipment and future shipments of condoms from the same 
manufacturer/shipper will directly relate to the manufacturers/shippers import history.  That 
history will determine which of three levels of detention is appropriate.    
The process used to make this determination is represented graphically in the flow chart provided 
on page 11.  Each stage of the process is cross-referenced with the corresponding flow chart 
decision, action, and outcome boxes in the discussion below.  
Level 1 Detention 
Criteria for Level 1 Detention (Flow Chart Decision Box D1): 
When DIOP receives a recommendation for detention, they should review 
the manufacturer/shippers import history to determine whether:  
  The manufacturer/shipper is currently listed on Import Alert #85-
04, or 
  The manufacturer/shipper has previously been listed on Import 
Alert #85-04 within an ongoing cycle.   
If it is determined that neither of these conditions apply, then Level 1 
detention is appropriate. If either condition is applicable, see the 
Criteria for Level 2 Detention and the Criteria for Level 3 
Detention sections below. 
Placement on Level 1 Detention   (Flow Chart Action Box L1): 
If the DIOP review determines that the manufacturer/shipper has not been listed previously on 
Import Alert 85-02 during an ongoing Cycle, and that the recommendation supports detention 
under the Act due to the appearance of a violation, the manufacturer/shipper should be listed on 
Attachment A of Import Alert #85-02 with a single asterisk ("*") along with the date of listing.  
In this manner, the date on which the condoms from that manufacturer/shipper are placed on 
Level 1 detention will initiate the firms Cycle.   
A firm may dispel the appearance of adulteration and obtain admission of subsequent individual 
shipments of condoms listed on the import alert by presenting evidence to the FDA field office at 
the port of entry that the individual shipments are not adulterated.  Evidence may include sample 
      4 Contains Nonbinding Recommendations 
 
 
testing performed by an independent private laboratory in the United States. The testing 
performed should follow the sampling plan contained in current CPG 7124.21.  For further 
information on how to submit private laboratory test results to FDA, refer to the Private 
Laboratory Guidance, found at Volume III, Section 7 of the ORA Laboratory Manual, available 
at http://www.fda.gov/ora/science_ref/lm/default.htm. 
 
Removal from Level 1 Detention:  (Flow Chart Decision Box D4) 
 To obtain removal of a manufacturer/shippers condoms from Level 1 detention under this 
guidance, a firm should provide documentation to DIOP that contains sufficient evidence to 
show that imported condoms from the identified manufacturer/shipper consistently meet FDAs 
acceptable quality criteria.  Evidence sufficient for removal of a manufacturer/shippers condoms 
from Level 1 detention will generally consist of independent private laboratory analyses, using 
FDAs sampling plans and test methods, showing that a minimum of five consecutive condom 
shipments meet the FDA acceptable quality criteria. For further information on removal from 
detention refer to the Request for Release from Detention section on page 9 of this document. 
Important Note: (Flow Chart Outcome Box O1) 
Even when a manufacturers/shippers condoms have been removed from Level 1 
detention, if another shipment of condoms from this same manufacturer/shipper 
fails analysis during the remainder of the Cycle, FDA should consider the 
previous placement on Level 1 detention when making further decisions regarding 
detention of the manufacturer/shippers imports.  (See Level 2 Detention 
below.) 
Level 2 Detention 
Criteria for Level 2 Detention:  (Flow Chart Decision Boxes D1, D2) 
When DIOP receives a recommendation for detention, they should review 
the manufacturer/shippers import history.   If DIOP determines that there 
is an ongoing Cycle and:  
  the manufacturer/shipper was previously listed on Import Alert 
#85-02,  Level 1 Detention, as discussed above (Criteria for Level 
1 Detention) during this Cycle but its condoms were removed 
from the import alert without advancing  to Level 2 Detention, or 
   the manufacturer/shipper is currently listed on Import Alert #85-
02, Level 1 Detention, and there is further evidence that its 
condoms are adulterated, such as a violative private laboratory 
(or FDA) analysis 
      5 Contains Nonbinding Recommendations 
 
 
then DIOP will notify CDRH.  CDRH and DIOP will both review the 
manufacturer/shippers import history to determine if the evidence supports 
placing condoms from that manufacturer/shipper on Level 2 detention.  
Placement on Level 2 Detention:   (Flow Chart Action Box L2) 
If the DIOP/CDRH review determines the recommendation supports detention under the Act due 
to the appearance of a violation and that the criteria for Level 2 detention have been met then the 
manufacturer/shippers name should be listed on Attachment A of Import Alert #85-02 with two 
asterisks ("**") and the date that its condoms were most recently placed on Level 1 detention.  
At the same time, CDRH should notify the foreign manufacturer/shipper in writing about 
possible deficiencies in their manufacturing procedures and practices that may be affecting the 
quality of the condoms offered for import to the United States.  The letter should advise the 
foreign manufacturer/shipper  that continued failure of its condoms to meet FDAs acceptable 
quality criteria may create an appearance that the manufacturer/shippers  manufacturing process 
does not satisfy the Quality Systems requirements promulgated under section 520(f) of the Act. 
Such an appearance would constitute the basis for detention of imports under section 801(a)(1) 
until FDA receives satisfactory evidence of compliance with the Quality Systems requirements.  
Manufacturers will be advised that they should review their manufacturing procedures and 
practices to assure that they are in accordance with the Quality System regulation (21 CFR Part 
820).  If the review shows that corrections are necessary to ensure condoms of acceptable 
quality, then such corrections should be made prior to offering further shipments of condoms for 
entry to the United States.  A copy of the Quality System regulation should be attached to the 
letter for the manufacturer/shippers information. 
A firm may dispel the appearance of adulteration and obtain admission of subsequent individual 
shipments of condoms from a manufacturer/shipper listed on Import Alert #85-02, Level 2 
detention, by presenting evidence to the FDA field office at the port of entry that the individual 
shipments are not adulterated.  Evidence may include sample testing performed by an 
independent private laboratory in the United States. 
Removal from Level 2 Detention:  (Flow Chart Decision Box D3) 
To obtain removal of a manufacturer/shippers condoms from Level 2 detention under this 
guidance, a firm should provide documentation to DIOP that contains sufficient evidence to 
show that the imported condoms consistently meet FDAs acceptable quality criteria.  Due to its 
increased concerns at Level 2 regarding the ability of the manufacturer/shippers condoms to 
meet the FDA criteria, FDA may need greater assurance than is needed for removal from Level 1 
detention.  Evidence sufficient  for removal of a manufacturer/shippers condoms from Level 2  
detention will generally consist of independent private laboratory analyses, using FDAs 
sampling plans and test methods, showing that  a minimum of ten consecutive condom 
shipments meet the FDA acceptable quality criteria.  For further information on removal from 
detention refer to the Request for Release from Detention section on page 9 of this document. 
 
      6 Contains Nonbinding Recommendations 
 
 
Important Note:   (Flow Chart Outcome Box O1) 
After DIOP receives adequate evidence, FDA may remove the 
manufacturer/shippers condoms from Level 2 detention. However, if another 
shipment of condoms from this same manufacturer/shipper is found to be 
defective during the remainder of the Cycle, FDA should consider the history of 
Level 2 detention when making further decisions regarding detention of the 
manufacturer/shippers imports.  (See Level 3 Detention below.)   
Level 3 Detention  
Criteria for Level 3 Detention:  (Flow Chart Decision Boxes D1, D2) 
When DIOP receives a recommendation for detention, they should review 
the manufacturer/shippers import history.  If DIOP determines that there 
is an ongoing Cycle and:  
  the manufacturer/shipper was listed on Import Alert #85-02, Level 
2 Detention, during this Cycle but its condoms were removed from 
the import alert without advancing to Level 3 Detention,, or 
  the manufacturer/shipper is currently listed on Import Alert #85-
02, Level 2 Detention, and there is further evidence that its 
condoms are adulterated, such as a violative private laboratory 
(or FDA) analysis,  
DIOP will notify CDRH.   CDRH and DIOP will both review the 
manufacturer/shippers import history to determine if the evidence supports 
Level 3 detention. 
Placement on Level 3 Detention:   (Flow Chart Action Box L3) 
If the DIOP review determines the recommendation supports detention under the Act due to the 
appearance of a violation and that the Criteria for Level 3 Detention have been met, then the 
manufacturer/shipper should be listed temporarily on Attachment A of Import Alert #85-02 with 
three asterisks ("***") until CDRH completes its review of the supporting documents and other 
relevant information.  These documents may include, but are not limited to, results of FDA and 
private laboratory sample analysis, previous import history, and the status of the current Cycle. 
Firms attempting to import condoms that are in this temporary status may request entry of 
individual shipments based on independent private laboratory testing, conducted in accordance 
with CPG 7124.21, which indicates the shipment is of acceptable quality. 
Placement on Attachment B:   (Flow Chart Outcome Box O2) 
If the CDRH review finds that the supporting documents and other relevant information presents 
the appearance that the methods used in, or the facilities or controls used for, the manufacture, 
      7 Contains Nonbinding Recommendations 
 
 
packing or storage of the device at the manufacturer/shippers facility do not conform to the 
requirements of section 520(f), then future shipments of the condoms manufactured at that 
facility may be refused admission pursuant to section 801(a)(1)).  CDRH will then notify DIOP 
that they should list that manufacturer/shipper's facility on Attachment B of Import Alert #85-02 
. 
At the same time, CDRH should notify the foreign manufacturer/shipper  in writing  that there is 
an appearance of nonconformance to the requirements of section 520(f), and that future 
shipments of the manufacturer/shipper's  condoms may be refused admission in accordance with 
section 801(a)(1) until the manufacturer/shipper provides adequate evidence to rebut this 
appearance.  
Removal from Level 3 Detention (Attachment B):  
Test results showing that individual shipments of condoms meet FDAs minimum acceptable 
quality criteria generally will not be sufficient for removal from Level 3 detention. A history of 
repeated shipments of defective condoms can present the appearance of nonconformance with 
good manufacturing practices (section 520(f)).  Evidence showing that individual shipments of 
condoms are of acceptable quality and, therefore, not adulterated under section 501(c), may not 
be adequate to dispel the appearance of nonconformance with 520(f) because the condoms may 
have been produced under a manufacturing system that does not conform to good manufacturing 
practices.  The appearance of failure to comply with the requirements of 520(f) provides an 
independent basis for refusal of admission under section 801(a)(1).   
To correct the appearance of violations underlying detention without physical examination for 
condoms on Level 3 detention, a manufacturer should assess its manufacturing system and 
correct any systemic problems that underlie the apparent nonconformance with good 
manufacturing practices.   It should demonstrate to FDA/CDRH that the condoms produced at 
the facility listed on Attachment B are manufactured in accordance with the Quality System 
regulation.  Such evidence should include a FDA on-site inspection of the manufacturing 
facilities that indicate conformance with the Quality System regulation, or a written certification 
of conformance with the Quality System regulation provided by the manufacturer/shipper, 
together with the results of an independent audit performed by a qualified third party. 
After the manufacturer/shipper demonstrates to CDRH that the apparent systemic manufacturing 
problems have been corrected and that it is complying with section 520(f), CDRH will request 
that DIOP remove the manufacturer/shippers condoms from Level 3, Attachment B. The 
manufacturer/shippers condoms then will be placed on Attachment A of Import Alert #85-02 
with the statement: "[Firm name] was moved from Attachment B to Attachment A on [date], as 
the result of an establishment inspection of the firm. Products from this firm remain subject to 
DWPE. Districts should immediately report violative private laboratory results to DIOP 
Operations and Policy Branch" to indicate they have been removed from Level 3 but are now in 
an interim status pending submission of additional evidence to correct the appearance of 
adulteration under section 501(c) caused by the past violative shipments. While the 
manufacturer/shippers condoms are in this interim detention status, FDA may detain shipments 
of condoms without physical examination.  However, firms may obtain entry of individual 
      8 Contains Nonbinding Recommendations 
 
 
shipments by presenting evidence to the FDA field office at the port of entry to rebut the 
appearance of (501(c)) adulteration, such as independent private laboratory testing of individual 
shipments to demonstrate that the condoms meet FDAs acceptable quality criteria. 
With sufficient evidence, the manufacturer/shippers products may be removed from this interim 
status. Evidence sufficient for removal of a manufacturer/shippers condoms from this interim 
detention status will generally consist of independent private laboratory analyses, using FDAs 
sampling plans and test methods, showing that a minimum of five consecutive condom 
shipments meet the FDA acceptable quality criteria.   Removal from the interim detention status, 
subsequent to removal from Level 3 based on an acceptable FDA or third party inspection, ends 
the manufacturer/shippers current Cycle. At this point, a firm may request removal of its 
condoms from listing on Import Alert #85-02 (and termination of the Cycle) as described in the 
Request for Release from Detention section on page 9 of this document.  
If a manufacturer/shippers condoms are currently on Import Alert #85-02 in interim status and 
FDA receives further evidence of adulteration, such as a violative analysis from an independent 
private laboratory (or FDA), the field office at the port of entry should make a recommendation 
to DIOP for detention.  If the DIOP review determines that the recommendation supports 
detention under the Act due to the appearance of a violation, the manufacturer/shipper  should be 
listed on Attachment A of Import Alert #85-02 with a single asterisk ("*") along with the date of 
listing.  In this manner, the date on which the manufacturer/shippers condoms are placed on 
Level 1 detention will initiate a new import surveillance Cycle.  Likewise, if a Cycle has ended 
and a manufacturer/shipper's condoms removed from the Import Alert, but a future shipment of 
condoms from the same manufacturer/shipper is tested and found to be defective by FDA or an 
independent private laboratory, the manufacturer/shippers condoms may again be placed on 
Level 1, beginning a new Cycle.  Once a new Cycle has begun, the import history of the 
manufacturer/shippers condoms prior to the beginning of the new Cycle should not be taken into 
consideration for purposes of determining the import detention level.   
Request for Reconsideration of Detention Level 
A firm who believes that its condoms have been inappropriately placed on Level 2 or Level 3 
detention, may submit evidence to CDRH to rebut this placement.2  For example, the firm might 
present evidence that results of analyses indicating defects in its condoms were actually caused 
by type 1 sampling errors.3 It might also present evidence that previous defective shipments were 
found during a previously concluded Cycle, so that a new shipment of defective condoms should 
result at most in placement on Level 1 detention and initiation of a new Cycle. CDRH will 
review any such information submitted, in conjunction with the documents relating to the 
analyses of the condoms in question and evaluate which level of detention, if any, is appropriate.  
                                                           
2 Firms who believe their condoms have been inappropriately placed on Level 1 Detention should contact DIOP to attempt 
to rebut this placement. 
3 Type 1 sampling error is the probability that a sampling plan for attributes will reject a lot when true percent defective is equal 
to or less than (<) the Acceptable Quality Level (AQL), where the AQL is equal (=) to the percent defective that a sampling plan 
for attributes will accept with probability equal (=) to 0.95. 
 
      9 Contains Nonbinding Recommendations 
 
 
Request for Release from Detention Without Physical 
Examination  
In order for a manufacturer/shippers condoms to be removed from Attachment A of IA #85-02, 
FDA should be provided with satisfactory results of sample analyses for a number of consecutive 
shipments sufficient to demonstrate compliance with FDA requirements. The documentation 
should consist of  
  documentation, including FDA entry numbers showing the FDA release of a number of 
consecutive entries of the manufacturers devices sufficient to demonstrate compliance 
with FDA requirements, (see Removal from Level 1 Detention and Removal from 
Level 2 Detention) and  
  test records (analytical worksheets) from independent qualified U.S. testing laboratories 
using the FDA analytical worksheet form FDA 431 or equivalent. Testing performed at 
the manufacturing facility or by private laboratories in the country of origin may not be 
acceptable due to the potential for rapid degradation of condoms during shipment to the 
U.S.  
Firms may submit the appropriate documentation with a request for their condoms to be removed 
from the Import Alert and from Detention without Physical Examination to the following office 
in FDA: 
Division of Import Operations and Policy (DIOP) 
5600 Fishers Lane (HFC-170) 
Rockville, Maryland 20857 USA 
Phone: 301-443-6553 Fax: 301-594-0413 
If FDA agrees that the results of sample analysis or other evidence submitted demonstrate 
compliance of the manufacturer/shipper and condoms, then the manufacturer/shippers condoms 
will be removed from the Import Alert and no longer subject to Detention Without Physical 
Examination.  
Sampling 
Sampling should be conducted according to the sampling plan in CPG 7124.21 and the most 
recent applicable sampling guidance documents, including Import Alert #85-02. 
When an FDA field office wishes to sample an entry that includes various styles of condoms 
(e.g. unlubricated, lubricated, spermicidally lubricated, ribbed etc.), a separate sample should be 
taken for each style that the field office wishes to test.  Multiple styles should not be mixed in 
one sample. 
      10 Contains Nonbinding Recommendations 
 
 
If only one style of condom is sampled from a shipment that consists of several different styles 
and the sample fails the water leak test, there is an appearance of adulteration and the entire 
shipment should be refused entry. Conversely, if three samples from the same shipment are 
considered necessary and all fail the water leak test quality acceptance criteria, the shipment 
constitutes one failure under the current policy and only one recommendation for detention. 
When taking a sample of a condom style from a shipment that includes numerous boxes/cartons 
of that style, FDA staff should attempt to open several different cartons in order to obtain a 
representative sample. 
Further Information 
Questions or issues concerning science, science policy, sample collection, testing, preparation, or 
analytical methodology should be forwarded to the Division of Field Science at (301) 827-7605 
or (301) 827-7606. 
Questions concerning Compliance Policy Guide 7124.21, condom labeling, or other compliance 
issues should be forwarded to Center for Devices and Radiological Health, Office of 
Compliance, Division of Enforcement II, OB/GYN, Gastroenterology & Urology Branch at 
(240) 276-0115. 
 
      11 Contains Nonbinding Recommendations 
 
 
 
FLOW CHART OF DETENTION LEVEL DETERMINATION 
Input 
Recommendation for detention 
based on failure of sample 
No  Is there an 
ongoing detention 
Cycle? 
D1
Yes 
IA 85-02 Att. B 
Firm previously  Yes Lab analyses 
on Level 2 this       Level 3  not sufficient 
cycle?  for removal 
D2  L3 from Level 3  
O2
No 
  24    Yes 
months 
     Level 2  D5
expired?
L2 Cycle ends 
No  O3
No  Yes
Off detention list but cycle 
Pass 10 private 
continues. If another violative 
lab analyses? 
analysis found, begin at top 
of chart. 
Go to 
D3 O1
top of 
chart 
Yes
No  
L1 Pass 5 private lab 
Level 1  
Go to 
analyses (with no 
(start cycle) 
top of 
failures)?
D4 chart 
 
      12