The US FDA said the examples outlined in the letter for Apotex “are of serious CGMP violations demonstrating that your quality system does not adequately ensure the accuracy and integrity of the data generated at your facility to ensure the safety, effectiveness, and quality of the drug products you manufacture. We found that your quality system failed to ensure the adequate investigation and resolution of quality failures.”
The history of the company’s working with the FDA to resolve cGMP violations is extensive. In April, the agency banned the facility from importing its products to the US, while back in March 2012, Apotex sued the agency over a similar import alert.
The FDA most recently takes issue with Apotex’s response to the violations uncovered during the June inspection. “Your response and comments focus primarily on the issue of intent, and do not adequately address the seriousness of the CGMP violations found during the inspection,” the agency says.
QC personnel from Apotex were also cited for creating unauthorized folders on laboratory computerized systems without appropriate oversight.
“FDA’s concern pertains to the practice of disregarding failing results, conducting trial injections and retesting products without any investigation. We are also concerned that you do not have documentation to support your decision to retest samples of lots that had initially failed to meet specifications, and you allowed manufacturing activities to occur without the oversight of your quality unit,” the agency says.
The agency says it’s seeking “a detailed description of all computerized systems in your facility used for testing drugs,” as well as “information on each electronic folder that was not created pursuant to a valid SOP [standard operating procedure] and an assessment of every file in each such folder.”
Apotex spokesman Steve Giuli told us: “Receipt of a warning letter after issuance of an import alert is standard practice by the FDA. To ensure all of our facilities continue to meet the highest quality and safety standards Apotex has dedicated significant resources to further reinforce our culture of quality. We have implemented improved training programs and applied new procedures to mitigate the risk of employee error through enhanced quality assurance measures and third-party validators. Customers can remain confident that our medicines are safe, effective, and will remain available on a reliable schedule.”
Similarly to Apotex, Micro was cited with data integrity issues when an inspection from May “identified laboratory test records that you did not review and evaluate in making batch release decisions. These records contained uninvestigated, out of specification (OOS) data,” the FDA said in its letter.
The company was also cited, just as Apotex was, for using “trial” sample injection even after the approval of a new SOP that the company’s quality system and management failed to detect and correct.
The agency “strongly” recommends that Micro hires a qualified third party auditor/consultant to help the company come into compliance with regulations and statutory authorities.
Micro Labs did not respond to a request for comment.