The FDA has issued an import alert against products manufactured at two Apotex facilities after the agency issued a warning letter, which raised several issues that the company is now working to resolve.
In a press statement Canada-based Apotex sought to clarify that the import ban only affects two of its “many facilities” and is only applicable to products destined for the US.
Apotex was issued with the warning letter on June 25. In the letter the FDA detailed “significant deviations” from current good manufacturing practices (cGMP) in the manufacture of non-sterile oral dosage products.
After receiving FDA 483 observations Apotex initiated corrections, some of which were completed when the warning letter was issued, but the agency stated the actions failed “to adequately address multiple, serious deficiencies”.
These alleged deficiencies include the failure to thoroughly investigate rejected batches. According to the FDA in the two years from December 2006 Apotex rejected 554 batches that failed to meet specifications but records of subsequent investigations were not provided.
Furthermore, the warning letters states that two of these rejected batches may have been shipped to the US. The FDA is seeking clarification of whether these were partially rejected batches, with only the products that passed testing being shipped to the US.
Overall the agency believes that these deficiencies, and other alleged issues at Apotex, “illustrate problems in the quality control unit's ability to conduct thorough investigations”.
Apotex said it is “actively working with the FDA to resolve the identified concerns as quickly as possible” and is optimistic that the matter will be resolved promptly.
Owing to time differences in-PharmaTechnologist was unable to contact Apotex or the FDA.