The FDA issued a warning letter to a south China OTC drug manufacturer for significant quality lapses, including a lack of testing.
Zhuhai Aofute Medical Technology failed to perform critical quality control tests for finished over-the-counter drug products, the agency found. Specifically, none of the batches of its Magic Spray for Pain Relief were tested for identity and strength, and facility staff said the company didn’t test incoming components.
The company’s quality unit was called out for failing to carry out basic tasks, including reviews of production and control records, approvals of procedures and specifications for drug quality attributes, and establishing proper batch records.
The investigator found that the company had “no meaningful production records” and operators routinely threw out raw data.