US FDA slams Suzhou Pharmaceutical Technology for copy and paste CoAs
The breaches of good manufacturing practice (cGMP) were flagged in a warning letter this week, along with details of an inspection of the firm's facility in Suzhou, China.
Faked quality documents were the Food and Drug Administration's (FDA) main concern.
The agency said that rather than testing ingredients from its suppliers, Suzhou had generated the CoAs it provided to customers by “copying and pasting” analytical results and replacing the manufacturer’s information with its own letterhead.
The US regulator warned that omitting manufacturing information from CoAs "compromises supply-chain accountability and traceability, and may put consumers at risk.”
Banned supplier
Also, according to the FDA, Suzhou claimed to have made an API batch shipped to the US in May 2015 whereas the ingredient was actually produced by a third-party supplier that had been on import alert since 2014.
In addition, the agency also criticised the firm’s API storage facilities at the Suzhou site, specifically the lack of temperature controls.
In the letter the FDA said that Suzhou response to the inspection, which was submitted by the firm last August, was inadequate because it did not provide details of corrective actions.
Suzhou did not respond to a request for comment.
