Disregard of contamination control procedures and improper inspection of raw materials are two of 10 observations made by FDA inspectors during a late 2009 inspection of the plant where Amylin makes the diabetes drug Bydureon. The Form 483 report was released last week, just as regulators issued a complete response letter for a long-acting version of the drug.
As we have reported, the once-weekly formulation, Bydureon, is being delayed because of labeling, risk strategy, and manufacturing process concerns, none of which are related to the Form 483 citations. "All of those observations have been addressed," the company says in an announcement.
The troubled plant, which is near Cincinnati, was also cited for failing to test in-process materials properly, and for lack of follow up on investigations into batch failures. Training and the following of procedures were also issues.
- see the Form 483
- here's the announcement
Editor's Note: This article originally stated that the FDA was inspecting Amylin's Byetta production facility. The inspection was for the diabetes drug Bydureon.