FDA WARNING_LETTER - KVK Tech, Inc. - April 16, 2019

The FDA issued a Warning Letter to KVK-Tech, Inc. following an inspection from April 9-16, 2019, identifying significant CGMP violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to establish and document test method accuracy (21 CFR 211.165(e))**: The firm improperly integrated co-eluting peaks during impurity testing of phentermine HCL capsules, leading to missed OOS results. A lot remained on the market until it failed stability testing in June 2017, despite self-identifying the issue in 2016 and conducting training. An SOP cleared by their quality unit contained inadequate integration examples. 2. **Failure to thoroughly investigate discrepancies (21 CFR 211.192)**: Foreign particles found in methylphenidate oral solution Lot #15315A were not adequately investigated for origin or effect on quality before release. This lot was later recalled. 3. **Inadequate computer system controls (21 CFR 211.68(b))**: Laboratory data was not adequately protected from deletion or alteration. Quality assurance employees had administrator access to chromatographic software, and data files on stand-alone equipment could be modified without audit trails. Previous corrective actions for data integrity were not fully implemented.

The FDA expressed concern about the firm's data integrity and recommended retaining