The U.S. Food and Drug Administration (FDA) has issued a warning letter to Sunstar Guangzhou following the inspection of the company’s drug manufacturing facility.
The warning letter summarized significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
During the inspection, FDA investigators observed specific violations including, but not limited to, the following:
The firm failed to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and conduct appropriate laboratory testing for each batch of drug product required to be free of objectionable microorganisms.
The firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.
The firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that all components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.
Failure to establish an adequate quality control unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
“FDA may withhold approval of requests for export certificates and approval of pending new drug applications or supplements listing your facility as a supplier or manufacturer until the above violations are corrected. We may re-inspect to verify that you have completed your corrective actions,” according to the letter from the FDA.