Dongkuk Techco Rubber Ind. Sdn Bhd 12/30/08

DEC 30 2008

WARNING LETTER

VIA FEDERAL EXPRESS

Mr. Peter Park
General Manager
Dongkuk Techco Rubber Industries, Sdn. Bhd.
7th Floor, Mayban Trust Bldg
3 Penang Street
Penang 10200
Malaysia

Dear Mr. Park:

During an inspection of your firm located in Sungai Petani, Kedah, Malaysia on June 23, 2008 to June 27, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Multi-colored, Lubricated, Ribbed-Dotted Contour, Black, Plain and Natural Plain 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 cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any 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. § 35I(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 (CFR),
Part 820. These violations include, but are not limited to, the following:

1. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b). For example, your Quality Assurance Manager failed to document and monitor the design and development activities in accordance with your firm's Design and Development Planning procedure (b)(4)

2. Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's development, as required by 21 CFR 820.30(e). For example, you failed to implement your procedure that requires each design review to include representatives of all functions concerned with the design stage being reviewed, You also failed to document that an individual who performed the design review did not have direct responsibility of the design stage being reviewed.

3. Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h). For example, you failed to follow your Design Transfer Procedure, (b)(4) which indicates documentation and development planning records must be properly documented.

4. Failure to establish and maintain a device design history file (DHF) for each type of device that contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the design control requirements, as required by 21 CFR 820.30(j). For example, you failed to follow your firm's Design History File standard operating procedure (b)(4) and did not develop a design history file for the rib contour, natural plain, black plain and multi-color condoms.

5. Failure to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, you failed to follow your firm's Design Changes Procedure (b)(4) which states that if a change is required during design and development planning or design reviews, a requester shall complete the Design Review/Change Report (b)(4) and that the requester shall clearly state that change criteria and the reason for the change on the report. This procedure was not followed for the design changes that were made involving the spermicidal lubricant condom product.

6. Failure to establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements, as required by 21 CFR 820.30(d). For example, you failed to document that design output meets the design input with respect to dimensions, bursting volume and pressure, tensile properties, seal integrity, as stated in the Design Input Procedure (b)(4)and Design Output Procedure (b)(4)

7. Failure to establish and maintain procedures to control product that does not conform to specified requirements and to identify, document, evaluate, segregate and dispose of nonconforming products, as required by 21 CFR 820.90(a). For example, a black plastic bag containing nonconforming (b)(4) was stored on top of conforming product labeled (b)(4) Furthermore, you failed to follow your firm's Standard Operating Procedure (b)(4) in that a black bag containing non-conforming product did not have a "reject sticker" placed on the bag and had not been transferred to the designated area for nonconforming products.

8. Failure to establish and maintain procedures to ensure the documentation of equipment identification, calibration dates, the individual performing each calibration, and the next calibration date, and failure to display such calibration records on or near each piece of equipment or readily available records to personnel using such equipment and to the individuals calibrating the equipment, as required by 21 CFR 820.72(b)(2). For example, there was incomplete documentation of the next calibration date for inspection, measurement and test equipment. The inspector found that the calibration stickers on various pieces of equipment were not changed (b)(4) equipment had incorrect dates transcribed on calibration stickers (e.g. (b)(4), and were absent (b)(4)

9. Failure to establish and maintain procedures for quality audits and conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, and failure ensure such audits are conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22. For example, you failed to follow your Quality Audit procedure (b)(4) in that:

(a) Quality audits for powdering and testing, sealing, packaging for condom and finger cot, purchasing, contract review, customer complaint, design control, inspection and testing, calibration, control of nonconformance, training, statistical techniques and technical file documents were not conducted for 2007.
(b) Audits for sealing, customer complaint, design control design control, corrective and preventive action, internal quality audit, statistical techniques and management reviews of departments were not conducted for 2006, and;
(c) A Contract Review audit for 2006 was conducted by the General Manager who has overall responsibility for the matters audited.

10. Failure to establish and maintain procedures to control all documents that are required by 21 CFR Part 820, and failure to promptly remove obsolete documents from all points of use, as required by 21 CFR 820.40(a). For example, documents that were not approved were observed at a location where they were being used. Specifically, copies of (b)(4) were found in use for a (b)(4).  This was not consistent with the firm's (b)(4) which stated that (b)(4) was in use.

Given the serious nature of the violations of the Act, the Multi-colored, Lubricated, Ribbed-Dotted Contour, Black, Plain and Natural Plain 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 Waming 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 Mr. Allen Wynn, Branch Chief, CDRH Office of Compliance, Food and Drug Administration, 2094 Gaither Road, Rockville, MD 20857. If you have any questions about the content of this letter, please contact Mr. Wynn at 240-276-0131.

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 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 violations, and take prompt actions to correct the violations and to bring your product into compliance.

Sincerely yours

/S/

Timothy A. Ulatowski

Director
Office of Compliance
Center for Devices and
Radiological Health

Cc: Mr. Jefferey Hackett
U.S. Agent Dongkuk Techco Rubber Industries, Sdn Bhd
Glimex Corporaton
705-2 East Bidwell Street
Suite 131
Folsom, CA 95630