IA #85-02, REVISED - 3/17/98, IMPORT ALERT 85-02, "SURVEILLANCE (100%
SAMPLING) AND DETENTION WITHOUT PHYSICAL EXAMINATION OF
CONDOMS", ATTACHMENT 12/3/03
(Note: This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or product(s) at issue. It
does not create or confer any rights for or on any person, and does not
operate to bind FDA or the public.)
REASON FOR
REISSUANCE : A new procedure has been developed for detention without
physical examination of condoms manufactured by firms that
repeatedly ship non-compliant products to the U.S.
TYPE OF ALERT : Surveillance (100% Sampling) and Detention Without Physical
Examination
PRODUCT : Condoms made from latex or synthetic material (this import
alert does not apply to natural membrane condoms nor to
female condoms.)
PRODUCT CODE : 85HIS, 85LTZ, 85MOL
PROBLEM : Defects/Holes
(OASIS CHARGE CODES: HOLES; FALSE; DEVICE GMP)
PROBLEM AREA
FLAG : PER, LBL
PAC FOR
COLLECTION : 82Z002
COUNTRY : See Attachment
MANUFACTURER/
SHIPPER : See Attachment
MANUFACTURER/
SHIPPER ID# : N/A
IMPORTER'S ID# : N/A
CHARGE : For lots that exceed an Acceptable Quality Level (AQL) of
0.4%:
"The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to contain
defects/holes [Adulteration, section 501(c)]." (OASIS CHARGE
CODE = HOLES)
If the condoms are labeled for the prevention of disease,
also charge:
"The article is subject to refusal of admission pursuant to
section 801(a)(3) in that the labeling for disease
prevention is false or misleading because the device
contains defects/holes [Misbranding, section 502(a)]."
(OASIS CHARGE CODE = FALSE)
When FDA has documented repeated violations, and the
manufacturer/ shipper has been issued a Warning Letter and
listed in Attachment B of the import alert per the
Recidivist Policy described below, future shipments may be
detained charging the following:
"The article is subject to refusal of admission pursuant to
section 801(a)(1) in that it appears that the methods used
in, or the facilities and controls used for, the
manufacture, packaging, storage, or installation of the
device do not conform with Good Manufacturing Practices
[Adulteration, section 501(h), Good Manufacturing Practices,
section 520(f)]." (OASIS CHARGE CODE = DEVICE GMP)
RECOMMENDING
OFFICE : Center for Devices and Radiological Health (CDRH)
REASON FOR
ALERT : Consumers rely on condoms for protection from HIV (AIDS) and
other sexually transmitted diseases (STDs). Defective
condoms present a potential hazard to health. Therefore,
continuous monitoring of these devices is needed.
GUIDANCE : Districts may detain without physical examination, all
shipments of condoms from the manufacturers/shippers listed
on the attachments to this alert.
Districts should collect representative samples from all
other shipments of imported latex or synthetic material
condoms that are not on detention without physical
examination.
Representative sampling of these entries is to be performed
on a 100% basis regardless of the manufacturer's history of
test results.
NOTE: Because the presence of defects in condoms represents
a potential hazard to health, only one (1) violative sample
is needed to submit a recommendation for detention without
physical examination to the Division of Import Operations &
Policy (DIOP). DIOP has direct reference authority for
detention without physical examination of condoms. Violative
condoms are subject to RPM Chapter 9, Detention Without
Physical Examination, subchapter "Recommendations Based on
One Sample."
The following procedure has been developed to address those
manufacturers/shippers who are found to repeatedly ship
violative condoms to the U.S. (recidivist firms.)
Level 1 Detention (INDICATED BY (*) IN ATTACHMENT A)
When a district encounters a shipment of condoms which is
found violative for defects by FDA analysis, the shipment
should be detained and a recommendation for detention
without physical examination should be forwarded to DIOP,
HFC-170.
If the recommendation meets current guidance, the
manufacturer/shipper will be placed on attachment "A" with a
single asterisk (*), and subsequent condom shipments from
that manufacturer/shipper may be detained without physical
examination. This is referred to as "Level 1 detention."
The importer may obtain admission of subsequently detained
shipments of condoms by presenting evidence that the
individual shipments are not adulterated, such as sample
analyses performed by an independent testing laboratory,
following the sampling plan and test method contained in FDA
guidance.
In order for the responsible manufacturer's/shipper's name
to be removed from attachment "A," documentation should be
provided with sufficient evidence that their condoms are not
adulterated (for example, five consecutive non-violative
shipments analyzed as described in the preceding paragraph
may be considered adequate evidence for manufacturers/
shippers to be removed from Level 1 detention).
Level 2 Detention -- (Recidivist firms which are
currently on Level 1 detention, or which have been removed
from Level 1 detention) (INDICATED BY (**) IN ATTACHMENT A)
If a manufacturer/shipper, while on Level 1 detention, has a
sample analyzed by an independent testing laboratory found
violative for defects, the district should notify DIOP and
submit supporting documentation. DIOP will place the firm on
Level 2 detention and identify the manufacturer/shipper on
attachment "A" with two asterisks (**).
Similarly, if a manufacturer/shipper that has been removed
from Level 1 detention has a sample analyzed by FDA and
found violative for defects within 24 months from the date
they were removed from Level 1 detention, the district
should notify DIOP and submit supporting documentation.
DIOP will verify the manufacturer/shipper was listed under
Level 1 detention during the past 24 months and if confirmed
will place the manufacturer/shipper on Level 2 detention and
identify the manufacturer/ shipper on attachment "A" with
two asterisks (**).
DIOP will notify CDRH of this action. CDRH will notify the
foreign firm in writing of FDA's concerns about potential
deficiencies in the manufacturing practices and process
controls which may be affecting the quality of the condoms
shipped to the U.S. A copy of the Quality Systems Regulation
will be provided with the letter for their information.
Once a manufacturer/shipper is placed on Level 2 detention,
FDA may need greater assurance that the condoms are not
adulterated before removing the manufacturer/shipper from
detention without physical examination status. For example,
10 consecutive non-violative shipments, analyzed by an
independent testing laboratory for defects, may be
considered adequate evidence that the manufacturer/shipper
is shipping condoms to the U.S. which are not adulterated.
Other types of evidence to remove the appearance of a
violation will be evaluated by CDRH on a case-by-case basis.
Level 3 Detention -- (Recidivist firms which are currently
on Level 2 detention, or which have been removed from Level
2 detention) (***) IN ATTACHMENT A DENOTES A WARNING LETTER
IS BEING CONSIDERED BY CDRH)
If a manufacturer/shipper, while on Level 2 detention, has
another sample analyzed and found violative for defects by
an independent testing laboratory, the district should
notify DIOP and submit supporting documentation.
Similarly, if a manufacturer/shipper who was removed from
Level 2 detention has another sample analyzed by FDA and has
been found violative for defects within 24 months from the
date they were removed from Level 1 detention, or from the
date they were placed on Level 2 detention, DIOP will bring
these instances to the attention of CDRH. DIOP will verify
the manufacturer/shipper was listed under Level 2 detention
during the past 24 months, and if confirmed will place the
manufacturer/shipper on attachment "A" with three asterisks
(***).
Based on the failure of the manufacturer's/shipper's condoms
to pass FDA analysis [Section 501(c)] after being listed on
Level 2 detention, or having failed an independent testing
laboratory's examination while under Level 2 detention, CDRH
may then issue a Warning Letter to the firm.
Additionally, after reviewing the manufacturer/shipper's
export and inspectional history, CDRH may elect to charge
the firm for failure to conform with GMPs [Section 501(h)],
based on the recurring Quality System Regulation
deficiencies as revealed by the repeated failures of
analyses. If CDRH determines a warning letter should issue
to the foreign manufacturer/shipper with a 501(h) charge,
DIOP will place the manufacturer/shipper on Level 3
detention (attachment B).
Non-violative analyses may not be sufficient to remove the
appearance of a violation for manufacturers/shippers on
attachment B. Manufacturers/ shippers will remain on Level
3 detention until evidence is provided to CDRH which
demonstrates that the condoms are being manufactured in
accordance with the Quality System Regulation (for example,
an acceptable FDA inspection or a written certification
from the manufacturer/shipper together with the results of
an independent audit performed by a qualified third party).
Once a foreign manufacturer/shipper satisfactorily
demonstrates that the apparent Quality System Regulations
deviations have been corrected, the manufacturer/shipper
will be removed from attachment "B" and placed on
attachment "A" under the Level 1 detention for individual
shipment analysis to confirm their condoms do not contain
defects until they provide adequate evidence to be removed
from Level 1 detention (see above).
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301)
443-3320 or 3007.
For questions concerning the Compliance Policy Guides (CPG),
condom labeling, or other compliance policy questions,
contact CDRH, Office of Compliance, Division of Enforcement
II at (301) 594-4616.
SAMPLING : See CPG 7124.21 for sampling plans.
PRIORITIZATION
GUIDANCE : N/A
FOI : No purging is required.
KEY WORDS : Condoms, latex, defects, holes, AIDS, synthetic material
PREPARED BY : Fredda Shere-Valenti, DIOP, (301) 443-6553
Rosa Forehand, DIOP (301), 443-6553
John Farnham, CDRH/OC/DOEII (301) 594-4616
DATE LOADED
INTO FIARS : March 17, 1998
ATTACHMENT A REVISED - 12/3/03
* = Firm is on Level 1 Detention
** = Firm is on Level 2 Detention
*** = Firm is being considered by CDRH for a Warning Letter
BANGLADESH
* Social Marketing Company Latex condoms
House No. 105 7/22/94
Road No. 9A
(New) Dhanmondl R/A Dhaka-1209
GPO Box 690, Dhaka, 1000
Bangladesh
MID# BDSOCMAR105DHA
CHILE
* Sagra Laboratory (Shipper) 5/6/94
Ignacio Valdivieso 2451
San Joaquin, Santiago, Chile
MID#CLSAGLAB2451SAN
CHINA, PROC
* Tianjin Medicines Health Products Partners brand Blue
Import and Export Tianjin Factory Spermicidally Lubricated
6 Tang Shan Road w/Nonoxynol-9, Extra
Tianjin, PROC Strength condoms
FEI# 1000179416 Partners brand Yellow
MID# CNTIAMED6TIA Spermicidally Lubricated
W/Nonoxynol-9 condoms
85HIS
8/1/96
GREECE
* Andreas S. Pappas Co. 2/18/94
19300 Aspropirgos
Athens, Greece
MID #GRANDPAP1930ATH
GERMANY
* Don Geschenkartikel-Neuheiten
Dolores Obidos-Naumann
Am Stadtbruch 14
P. O. Box 1170
3549 Volkmarsen, Germany
HONG KONG
* Anna Mfgr. Ltd 3/29/94
Hong Kong, Hong Kong
MID#HKANNMFGHON
HUNGARY
* Kamlord Co., Hong Kong
Industat Budapest KFT 3/29/94
Budapest, Hungary
MID#HUINDBUDBUD
INDIA
* M/S Hindustan Latex Limited Condoms (Bull
Poojappura, P.O. THIRUVANANTHAP Dog brand)
Kerala 695 012 India 2/3/95
ITALY
* Hatu-Ico
Bologna, Italy
JAPAN
* Fuji Latex Co., Ltd. Black Condoms
19-1, 3-Chome 2/25/93
Kanda Nishiki-Cho, Chiyoda-Ku,
Tokyo, Japan
KOREA
* Dongkuk Trading Co., Ltd.
Seoul, Korea
* Greenmate Corporation
1443-15 Seocho-Dong, 85HIS
Seocho-Ku 4/4/96
Seoul, Korea
FEI #1000529867
* Hyosung Corp., Korea
Main Office:
* Orient Medical Supply Co., Ltd. 12/13/90
Room 3403, Korean World Trade Center
159 Sam Sung Dong, Seoul, Korea
Manufacturing Site:
* Orient Medical Supply Co., Ltd.
258-1 Youngwon-Ree, Chunwon-Gun
Choong-Nam, Korea
*
Shinheng Corporation
Rm 1003, Daejun Bldg.
1318-4 Socho-Dong, Socho-Gu
Seoul, Korea
* Sol Medical Supply Co., Ltd.,
Seoul, Korea
MALAYSIA
* Asbien SDN BHD, Malaysia 10/1/92
(Factory)
* L.S. Rubber Sdn. Bhd. Condoms, flavored
PLO 22, Senai Industrial Estate 85H[][]IS
Phase 1, 81400 Senai 5/9/03
Johor, Malaysia
FEI#: 3002807508
THAILAND
* Ken Nona 3/29/94
also known as S.L.D International Co., Ltd
16 Asoke Road
Sukhumvit SOI 21
Prakanong, Bangkok, Thailand
MID#THSLDINT21BAN
* Royal Industries Thailand Co., Ltd.
218/5-6 Soi
Bangkok, Thailand
* S.L.D. International Co., Ltd. 3/15/94
16 Asoke Road
Sukhumvit SOI 21
Phrakanong, Bangkok, Thailand
10110
(ID# THSLDINT21BAN)
UNITED KINGDOM
* PHS, Limited Condoms with
Claymore, Tame Valley nonoxynol-9 1/10/95
Industrial Estate
Tamworth, Staffordshire
United Kingdom
ATTACHMENT B - Level 3 Detention
Warning Letters Issued
NO FIRMS LISTED AT THIS TIME