The FDA issued a warning letter to Chinese drugmaker Guangdong Zhanjiang Jimin Pharmaceutical following a May inspection of its Guangdong Province facility.
Investigators found that one of the APIs used in a topical OTC product was mislabeled as hydrocortisone — an error the firm blamed on a bad translation. But the company’s own records showed the API was actually dexamethasone acetate. The drugmaker recalled all lots of the drug distributed in the U.S., but failed to document its investigation into the mistake or a plan to prevent it from recurring.
The company also failed to assess drug products for the strength and identity of the API ahead of distribution and release. In addition, it did not conduct process performance qualification studies to ensure product quality and it had no program in place to monitor process controls.
The agency deemed the firm’s August response to the initial inspection observations inadequate, and it recommended the company engage a GMP consultant to correct the issues.