FDA WARNING_LETTER - Peking Medicine Manufactory - May 04, 2012

The FDA issued a Warning Letter to Peking Medicine Manufactory following an April 30 – May 4, 2012 inspection, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key CGMP deficiencies included a non-functioning Quality Control Unit (QCU) that failed to approve procedures/specifications, exercise authority over material disposition, and lacked written procedures (21 CFR 211.22). The firm also failed to establish scientifically sound specifications, sampling plans, and laboratory controls (21 CFR 211.160), and did not perform adequate laboratory testing for product release, relying on unverified Contract Manufacturer Certificates of Analysis (21 CFR 211.165(a)). Further violations involved the absence of an adequate stability testing program (21 CFR 211.166(a)), lacking written procedures for component control and improper storage (21 CFR 211.80(a) and (c)), failure to conduct identity testing for incoming materials (21 CFR 211.84(d)(1)), and inadequate employee CGMP training (21 CFR 211.25(a)). Beyond CGMP, the firm distributed STRONG WOO LOK GAO, an unapproved new drug, violating sections 301(d) and 505 of the Act, as it is not generally recognized as safe and effective and not covered by the OTC External Analgesics Tentative Final Monograph. A previous warning letter also cited failure to register and list (21 CFR Part 207.40). The FDA requires a written response within fifteen working days detailing corrective actions, including developing QCU procedures, specifications, calibration plans, stability programs, and addressing products on the U.S. market. Failure to comply may result in import refusal and withheld application approvals. The FDA recommended consulting a third-party expert.