The FDA cited French in vitro diagnostics player bioMérieux for a number of quality violations in a North Carolina manufacturing facility.
Regulators' Aug. 23 warning letter to CEO Jean-Luc Belingard stems from an inspection of the company's Durham, NC, facility conducted Jan. 24-March 6. They found fault with a number of processes involved in the production of diagnostic equipment. They also noted previously identified problems and a lack of proof that bioMérieux made promised changes. Regulators' concerns include:
Faulty seams in plastic bottles. Even after bioMérieux was cited for the problem in 2009 and a solution was identified, the company didn't take steps to correct the problem, the FDA claims. (The bottles are used for blood culture media.)
32 customer complaints regarding BacT/ALERT blood culture media that produced false positives. The FDA says the company didn't try to fix the problem despite complaints in 2010. A second investigation launched to evaluate a new round of complaints. FDA officials say they want more information, now that the company has proposed a solution, to see if it has done enough to fix any issues, according to the warning letter.
While bioMérieux said it came up with improvements to reduce the need to revamp production lots, the FDA isn't convinced the solutions are enough and the agency demands more details, the letter explains.
The FDA gave bioMérieux 15 business days to respond to the letter, and document steps it has taken to address noted problems and how it will prevent those violations from happening in the future.
This has been an otherwise smooth year for the company, which reported steady sales increases in its fiscal 2012 first quarter, driven, in part, by double-digit growth in the Asia-Pacific region, particularly China and India.
- read the warning letter
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