The ticking noise that Apotex President and COO Jack Kay has been hearing is the FDA's 15-day response clock running down after the drugmaker received Warning Letter 320-10-003. The letter cites "serious and repeat violations" from previous inspections. Apotex's response to those warnings, the regulator writes, "is inadequate and lacks sufficient corrective actions."
Contaminated drug ingredients, the return of defective material to inventory, and the re-release of failed material prior to sufficient reprocessing and testing are among the quality-control shortcomings at the Toronto facility. Inadequate written procedures for production and process controls are cited, as is the company's failure to investigate batch and component failures.
Lack of investigation into batch failures was also a central point in another warning letter, which the company received last year for its Etobicoke site. FDA inspectors noted that the company had rejected 554 batches of drug products and in-process materials over a two-year period, without keeping records of investigations.
The regulator writes in the current warning that the "identical CGMP violations demonstrate a lack of adequate process controls and raise serious questions regarding your corporation's quality and production systems."
We can hope that Apotex has fixes in the works, for Kay's sake. As we reported in March, the FDA has indicated it will pursue misdemeanor prosecutions for execs who make promises in responses to warning letters they don't keep.
- here's the current warning letter
- see our coverage of the company's 2009 letter