FDA Warns, Blocks Imports From Chinese API Manufacturer
Earlier this month, the US Food and Drug Administration (FDA) sent a warning letter to a Hubei, China-based active pharmaceutical ingredient (API) manufacturer related to several failures.
The letter issued to Hubei Danjiangkou Danao Pharmaceutical Co. notes the company’s failure to demonstrate that its manufacturing process can reproducibly manufacture an API meeting predetermined quality attributes, a failure of its quality unit to approve changes that potentially impact API quality and its failure to ensure that all test procedures are scientifically sound and appropriate.
The current good manufacturing practice (CGMP) failures cited by FDA followed an agency investigator’s uncovering of "numerous changes that were not adequately documented, and implemented without quality unit evaluation and approval per your procedure, Change Control. These changes included, but were not limited to, product specifications, test methods, analytical equipment, and cleaning procedures for the manufacturing of [redacted] API."
The letter also notes that the firm "did not perform process qualification studies and lacked an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality."
The release of the 6 November warning letter follows the addition of the API manufacturer to FDA’s import alert list on 1 November.