Fercy Personal Care Products received an FDA warning letter after quality staff handed inspectors just two pages from a notebook as ingredient records.
During a March visit, the US Food and Drug Administration (FDA) found the company was failing to inspect the quality of its drug product components, containers, closures, in-process materials, packaging materials and finished products.
The regulator said that, as a result, the Zhejiang, China based manufacturer’s finished products were adulterated with foreign bodies.
“The quality control unit failed to approve procedures and specifications impacting the identity, strength, quality and purity of the drug product,” the authority said in a letter to the firm .
“Additionally, records pertaining to the production and release of your drug products were not provided to the investigator for review. The only documentation available on site for the batches of drug products manufactured by your firm was two pages from a notebook listing the ingredients used.”