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Article: Dongkuk Techco Rubber Industries, Penang, Malaysia/Kedah, Malaysia.
- Article from:
- Warning Letter Bulletin
- Article date:
- September 13, 1999
CopyrightCOPYRIGHT 1999 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Dongkuk Techco Rubber Industries, Penang, Malaysia/Kedah, Malaysia, Aug.
18 (Office of Compliance). The agency found that Dongkuk violated the QS regulation in its condom manufacturing process by failing to establish design control requirements. The warning letter enumerated failures to "establish and maintain procedures for the identification, documentation, validation, or, where appropriate, verification, review and approval of design changes before...implementation." Inspectors also ...
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