"Who Makes This Drug?" FDA Issues Warning Letter to a Contract Manufacturer Over Documentation Discrepancies and Non-Cooperation
The firm appears to have denied manufacturing a prescription drug product shipped to the US, despite documentation suggesting otherwise.
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We read tons of FDA warning letters, but a recent one to a contract manufacturer based in India is genuinely novel. The letter came after the company allegedly failed to clarify its role in manufacturing a specific drug. More specifically, the firm appears to have denied manufacturing a prescription drug product shipped to the US, despite documentation suggesting otherwise.
Read the full warning letter »
The letters followed multiple attempts to obtain information from company leadership beginning in October last year. When the company finally responded, they denied manufacturing the product in question, contradicting evidence its own customer provided. This included a contract manufacturing agreement, the firm's CoA, and batch production records.
After it stopped responding to further inquiries, the FDA placed all of the company's products on Import Alert on February 12.
Here's a timeline of this strange (and concerning) series of events:
October 29, 2024: FDA sends an electronic request for records to the firm's contact email (provided in their customer's contract manufacturing agreement).
November 7, 2024: After no response, FDA sends a follow-up written request, confirmed delivered by the shipper.
November 13, 2024: The firm's VP of Quality responds via email, denying that they supply the product in question.
November 15, 2024: FDA sends a third request via email, which the firm fails to respond to.
February 12, 2025: FDA places all drugs manufactured by the firm on Import Alert 66-79, effectively blocking them from US import.
February 13, 2025: FDA issues this warning letter.
The FDA cited several pieces of evidence contradicting the company's denial:
A contract manufacturing agreement provided by the product owner
The company's own registration file with the FDA
A CoA
A batch production record for the drug in question
The lessons here should be obvious:
Manufacturers must be forthright about their production activities, especially for products entering the US market.
Prompt and honest responses to FDA inquiries are not optional if you intend on keeping products on the market.
Contradictions between manufacturer statements and documentary evidence are obviously going to immediately raise serious regulatory red flags.
Non-cooperation can result in sweeping import restrictions affecting a company's entire product line, not just the disputed product.
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