Dive Brief:
- Apotex Group's Indian manufacturing company, Apotex Research, picked up a warning letter from the Food and Drug Administration following an inspection last November that revealed a number of significant violations of current good manufacturing practices (cGMP). The company has been on import alert since April 2018.
- According to the letter, the company failed to investigate out-of-specification lab results and manufacturing deviations for capsules and tablets, and has not established valid in-process specifications.
- The FDA's letter also states that Apotex Research's quality unit does not have enough authority and its quality systems are inadequate. Because these are not the first violations, the FDA is calling for a cGMP consultant before the company's compliance status can be resolved.
Dive Insight:
This is the third time that a member of the Apotex Group has received warning letters and been on import alert in the past five years. Apotex Pharmachem India was slapped with an import alert in April 2014 and a warning letter in June of that year for failure to investigate and document out-of-specification results. Apotex Research would be given an import alert by September 2014 and a warning letter about four months later, citing failure to follow written procedures applicable to the quality control unit.
If this month's warning letter is any indication, Apotex Group hasn't learned from its mistakes.
The FDA's November 2017 inspection pointed out further failures to investigate out-of-specification laboratory results and manufacturing deviations. These included: excluding out-of-specification results and not investigating failing results for capsules.
The agency requires a response from Apotex Research within 15 working days, and failure to correct all of these violations may result in U.S. regulators withholding approval of any new applications or supplements.
Notably, the FDA's Office of Manufacturing Quality issued 43 warning letters between January and mid-August 2018. Overall, the number warning letters has increased. If they continue to rise, 2018's figures are likely to match or top the 61 issued in 2017.
Of the 43 warning letters issued this year, 32 were against facilities based in Asia. Even taking into account the amount of manufacturing carried out in the region, this still appears disproportionate. While Asian countries, including India and China, are fighting the reputation of lower quality manufacturing, this appears to be a battle that they are not yet winning.