FDA WARNING_LETTER - Dongkuk Techco Rubber Ind. Sdn Bhd - June 27, 2008

On June 23-27, 2008, an FDA inspection of Dongkuk Techco Rubber Industries, Sdn. Bhd. in Malaysia found their Multi-colored, Lubricated, Ribbed-Dotted Contour, Black, Plain and Natural Plain Condoms to be adulterated. The firm's manufacturing, packing, storage, or installation methods and controls did not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. Failure to establish and maintain design and development plans (21 CFR 820.30(b)). 2. Failure to establish and maintain procedures for formal documented design reviews (21 CFR 820.30(e)). 3. Failure to establish and maintain procedures to translate device design into production specifications (21 CFR 820.30(h)). 4. Failure to establish and maintain a device design history file (DHF) (21 CFR 820.30(j)). 5. Failure to establish and maintain procedures for design change control (21 CFR 820.30(i)). 6. Failure to establish and maintain procedures for defining and documenting design output (21 CFR 820.30(d)). 7. Failure to establish and maintain procedures to