Sagami Rubber Industries Co., Ltd. 11/24/10
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
November 24, 2010
Via United Parcel Service
Mr. Ichiro Oato
Sagami Rubber Industries Co., Ltd.
Dear Mr. Oato:
During an inspection of your firm, Sagami Manufacturers Sdn. Bhd., located in Perak, Malaysia on August 2 – 5, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Trojan Polyurethane Supra Condoms. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received a response from you dated September 1, 2010, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. Your response to the FDA 483 was not reviewed because it was not received within 15 business days. The response may be evaluated along with any other written material provided in response to this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example:
a. Your process validation for Polyurethane Condom/Dipping process line (b)(4) which is used for the Supra brand product that goes to the US did not document or define the process condition for the rate of entry of the (b)(4) molds into the dipping tank, the time that the (b)(4) mold is held in the dipping tank and the rate at which the (b)(4) mold is removed from the tank.
b. As part of the Polyurethane Condom/Dipping process, your hot air drying steps for the (b)(4) molds using HEPA filters have not been adequately validated to determine the integrity of the filters and/or when the filters should be replaced.
2. Failure to establish and maintain adequate procedures for implementing corrective and preventive action to include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1). For example, the quality data associated with your (b)(4)% visual examination of condoms (PU: APPEARANCE CHECK SHEET, Form# PT-7-1 Ver.8, Processing Dated: August 29, 2009, (b)(4) Product: 38-35C-190) identifies (b)(4) however, this quality data is not used to identify potential causes of nonconforming product, or other quality problems.
3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action to ensure activities required under this section, and their results, shall be documented, as required by 21 CFR 820.100(b). For example, the corrective and preventive actions pertaining to higher rates of testing failure of (b)(4) micron thickness polyurethane condoms/38-28C-170 & 38-28C-190 (product type) based on (b)(4) abnormality reports from 2009 and 2010 have not been documented according to your Corrective and Preventive Action/SOP-08-01. Investigation and corrective actions pertaining to the (b)(4) mold (used in dipping process) replacement schedules have been made but there is no documentation of these activities in your CAPA system.
Given the serious nature of the violations of the Act, the Trojan Polyurethane Supra Condoms manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made.
Also, U.S. federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your response should be sent to: Paul F. Tilton, Chief, Ob/Gyn, Gastroenterology, and Urology Devices Branch, WP66-3540, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, U.S.A. If you have any questions about the content of this letter please contact: Ronald T. Nowalk at (telephone) 301-796-5493 or (fax) 301-847-8137.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and