FDA WARNING_LETTER - Dasan E&T; Co., Ltd. - January 26, 2017

The FDA issued a Warning Letter to Dasan E&T Co., Ltd. following a January 23-26, 2017 inspection, citing significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test drug products prior to release (21 CFR 211.165(a))**: The firm released products without testing active ingredient identity and strength, and conformance with established levels of certain components. The provided response was inadequate due to a lack of specific details on testing attributes and methods. 2. **Inadequate laboratory controls (21 CFR 211.160(b))**: The firm failed to demonstrate the suitability of microbial limits test methods for their drug products. The response lacked sufficient detail or evidence of corrective actions. 3. **Failure to establish written procedures for production and process control (21 CFR 211.100(a))**: The firm had not validated manufacturing processes for drug products or their water system, which is used in drug products. Insufficient testing of the water system was also noted. The response was inadequate due to a lack of detail and evidence. 4. **Failure to conduct adequate testing of components (21 CFR 211.84(d)(1))**: The firm did not test glycerin raw material for diethylene