Samchundang Pharm Co., Ltd. – FDA Warning Letter, Oct 25, 2019

The FDA issued Warning Letter 320-20-35 to Samchundang Pharm Co., Ltd. on May 13, 2020, following an inspection from October 17-25, 2019. The letter identifies significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to establish and document test method accuracy (21 CFR 211.165(e))**: The firm did not validate sterility test methods for final release or in-process bioburden tests for their aseptically filled drug products. Their response, citing "lack of specific requirements" in contracts, was deemed inadequate as it failed to address interim risks for distributed products. 2. **Inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv))**: The firm did not routinely identify all isolates from aseptic processing areas, only identifying one isolate per morphological group. Personnel monitoring action limits were also deemed insufficient. Their proposed revisions were inadequate for not comprehensively addressing deficiencies or the impact on distributed drugs. 3. **Insufficient personnel training (21 CFR 211.25(a))**: Training deficiencies were noted across management, production, quality assurance, and quality control, including missed training intervals, uncertified analysts, and lack of training records. The firm