Another FDA warning letter for India-based Apotex
- The FDA has issued yet another warning letter to Apotex, which is based in Bangalore, citing serious manufacturing violations.
- Some examples of the most recent violations include failure to ensure that laboratory records included all necessary testing-compliance data; failure to ensure that only authorized personnel have access to the master control functions of the computer system; and failure to establish appropriate procedures to prevent bacteria from developing.
- Apotex is only one of the India-based generic drug manufacturers to come under scrutiny for quality-control problems, but according to the Wall Street Journal, "The FDA and Apotex have had a particularly contentious relationship."
The large-scale problem of quality-control issues at Indian pharmaceutical manufacturing facilities is well known, with a seemingly endless stream of product recalls, warning letters, and even revoked approvals. Even as companies like Sun Pharmaceuticals, Ranbaxy and now Apotex face scrutiny and requests for immediate responses, reform efforts have been underway for some time.
Unfortunately, Apotex is facing bigger problems, as they have failed to remediate many of the FDA complaints cited in earlier FDA warning letters, which date back to 2009. Apotex considers warning letters from the FDA 'standard practice' and has noted that it has been working on improving quality-control issues.
Unfortunately, it also has a history of suing the FDA and Health Canada, while continuing to pile up one warning after another. The problem is that there is more at stake than Apotex's and other manufacturers' corporate revenues: The entire pharmaceutical supply chain could be affected if these ongoing quality-control problems are not aggressively addressed and remediated.