US FDA slams Chinese API maker for unlocked records cabinet

By Flora Southey contact

- Last updated on GMT

Getty/Thomas Pajot
Getty/Thomas Pajot
The US FDA has issued Henan Lihua Pharmaceutical Co. Ltd. a warning letter and imposed an Import Alert 66-40 following inspections at two manufacturing facilities in Henan, China.

According to the warning letter​, which references site visits conducted in December last year, Henan Lihua Pharmaceutical failed to implement appropriate controls over its batch manufacturing records.

“Our investigator observed numerous blank batch manufacturing records in an open cabinet in your manufacturing workshop office,” ​said the Agency.

The investigator also observed two record issuance stamps – for batch and page number – in the open cabinet, the FDA continued: “You also said the quality unit record controller ‘did not realize the risk of the damaged lock’ on the cabinet containing the records and stamps.”

The FDA also flagged discarded raw data from laboratory tests on-site: “It is essential to retain raw data to ensure the ability to reconstruct CGMP [current good manufacturing practice] activities and to review raw data, as necessary, for CGMP control testing.”

Henan Lihua Pharmaceutical agreed to hire a third-party consultant to address the concerns.

The firm did not respond to a request for comment ahead of publication.

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