FDA WARNING_LETTER - Hubei Danao Pharmaceutical Co., Ltd. - August 04, 2017

The FDA inspected Hubei Danjiangkou Danao Pharmaceutical Co., Ltd. from July 31 to August 4, 2017, identifying significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated. The company's August 25, 2017, response was deemed inadequate.

Key violations include: 1. **Failure to validate manufacturing processes:** The company did not validate processes for numerous API batches prior to commercial distribution, lacked process qualification studies, and an ongoing program for monitoring process control. Batch records also lacked defined critical process parameters. 2. **Failure of quality unit to approve changes:** The firm failed to follow its change management program, implementing numerous undocumented changes without quality unit evaluation and approval, including product specifications, test methods, analytical equipment, and cleaning procedures. 3. **Failure to ensure scientifically sound test procedures:** Inadequate test procedures were observed, such as manual integration of a high-performance liquid chromatography test for API despite lacking peak resolution, without an approved protocol or quality oversight.

The FDA strongly recommended engaging a qualified CGMP consultant. The deviations are not an exhaustive list, and the company is responsible for investigation, root cause determination, and recurrence prevention. The firm was placed on Import Alert 66-40 on November 1, 2017. Failure to correct deviations may result in withheld approval of new applications and continued