FDA WARNING_LETTER - Enprani Co., Ltd. - March 15, 2019

The FDA issued a Warning Letter to Enprani Co., Ltd. following an inspection from March 11-15, 2019, at their Incheon, South Korea drug manufacturing facility. The letter identifies significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Lack of Final Product Testing:** The firm released OTC drug products to the U.S. market without testing for identity and strength of active ingredients, and raw data for reported tests were unavailable. 2. **Inadequate Quality Control Unit:** The Quality Unit (QU) lacked sufficient oversight and authority, failing to ensure drug quality. 3. **Absence of Process Validation:** The firm failed to establish written procedures for production and process control, lacking process performance qualification studies and an ongoing monitoring program. 4. **Insufficient Stability Program:** Inadequate stability data existed to support assigned expiry periods, with initial studies failing to analyze for assay and impurities at appropriate intervals. 5. **Inadequate Computer System Controls/Data Integrity:** Laboratory equipment lacked restricted access, allowing unauthorized data manipulation (overwrite, delete, copy, rename), and audit trails were turned off.

Additionally, Enprani Co., Ltd. failed to maintain current establishment registration and list drugs manufactured at the facility, as required by sections 510(