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