Luen Fook Medicine Sdn. Bhd. – FDA Warning Letter, Dec 14, 2018

The FDA inspected Luen Fook Medicine Sdn., Bhd. in Malaysia from December 10-14, 2018, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm's African "SEA-COCONUT" Sore Throat Syrup was also cited as an unapproved new drug, violating 21 U.S.C. 355(a).

Key violations include: 1. Failure to test finished drug products for identity and strength of active ingredients prior to release (21 CFR 211.165(a)). 2. Failure to establish written procedures for production and process control, and lack of process validation for African "SEA-COCONUT" Sore Throat Syrup (21 CFR 211.100(a)). 3. Failure to perform cleaning validation for equipment and inadequate cleaning procedures (21 CFR 211.67(a)). 4. Inadequate quality control unit oversight (21 CFR 211.22(a)).

These are repeat violations from a May 2015 inspection, indicating inadequate executive management oversight. The FDA recommends engaging a qualified consultant (21 CFR 211.34) for CGMP compliance.

The African "SEA-COCON