FDA WARNING_LETTER - Henan Lihua Pharmaceutical Co., Ltd. - December 14, 2017

The FDA inspected Henan Lihua Pharmaceutical Co. Ltd.'s drug manufacturing facilities in Anyang, Henan, China, from December 11-14, 2017, identifying significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Failure of the quality unit to review and approve quality-related documents:** Uncontrolled blank batch manufacturing records and product release forms with "Permitted to Leave Factory" stamps, along with record issuance stamps, were found. The company's response, citing convenience and a damaged lock, was deemed inadequate as it did not assure adequately trained personnel. 2. **Failure to maintain complete laboratory test data:** A (b)(4) instrument used for stability and in-process testing allowed continuous "preview run" function and overwriting of previous runs, retaining only the final run. This prevented reconstruction of CGMP activities and review of raw data. The company's plan to replace instruments was deemed insufficient without proper data retention procedures.

The FDA requires a comprehensive data integrity remediation plan, including: A. A thorough investigation into data inaccuracies, including interviews (preferably by a third party) and an assessment of data integrity deficiencies across all operations. B. A current risk assessment of the impact of these failures on drug quality and patient safety. C. A management strategy detailing a global corrective and preventive