The US Food and Drug Administration (FDA) criticised Cheng Fong in a warning letter published this week. The letter also covered the Taiwan firm’s response to current good manufacturing practice (cGMP) deviations observed during an April inspection.
The agency acknowledged Cheng Fong had addressed its facility and maintenance concerns, but said its identification of “manufacturing equipment” as the source of foreign particles in batches of APIs was not a sufficient explanation.
“Your investigations into poor equipment maintenance and foreign particles are inadequate as you did not identify the foreign matter in your API, or sufficiently extend the investigations to other lots that may have been contaminated.”
The FDA also raised concerns about Cheng Fong’s initial response to the customer complaint.
According to the letter, rather than examine reserve samples of the batch in which a customer found foreign particles, Cheng Fong examined a different batch. The second batch was also found to contain foreign particles.
The agency reminded Cheng Fong that: “Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.”
Cheng Fong has 15 days to respond.
The firm did not respond to a request for comment.