UPDATED
FDA delivers warning to Chinese company after no response to Form 483
In the warning letter, the US Food and Drug Administration (FDA) highlighted that inspections revealed issues, which had previously led to the issuance of Form 483, regarding relabeling active pharmaceutical ingredient (API) without noting the original manufacturer and failure in quality control.
The FDA stated that it had not received a response regarding corrective action taken to the two observations noted and had placed Yino Inc. on Import Alert 66-40 on August 1, 2019.
Yino is a Chinese company located in Chongqing and supplies asparaginase to the US market, a spokesperson for the company told us.
The warning letter notes, “[The company] re-labels API manufactured by other manufacturers and distribute the API to other facilities.”
The FDA identified that the relabeled API did not feature the name or address of the original manufacturer on certificates of analysis (COA). The agency highlighted that regulators and customers rely on COA for accurate information about the quality and source of drugs.
In addition, the agency observed that the COA of several lots of the company’s API did not feature a signature or date from an authorized person in the quality unit.
On these lots, the FDA found “a test parameter and result that was not performed by the original API manufacturer, nor could [the company] provide evidence that [it] had performed the test.”
The spokesperson told us, "Response to Form 483 was sent to and confirmed by the FDA's Office for Pharmaceutical Quality Operations. However, it appears the Center for Drug Evaluation and Research Office of Manufacturing Quality did not receive the response and issued the warning letter."
The company has since submitted a response to the waning letter and "expects that the warning letter will be withdrawn soon," the spokesperson confirmed.
Update: The article has been updated to correct the named company to Yino Inc., and quotes have been added by the company involved.
