FDA 483 - Akorn Operating Company LLC - May 19, 2011

From May 9 to May 19, 2011, the FDA inspected Akorn Inc., a sterile drug manufacturer located at 72 Veronica Ave, Somerset, NJ 08873. The inspection was conducted by Investigator Paul Bellamy and the report was issued to Michael P. Stehn, Vice President and General Manager.

The primary observation noted was that the testing and release of drug products for distribution did not include appropriate laboratory determination of satisfactory conformance to final specifications prior to release, specifically due to insufficient data, documentation, and evidence to invalidate Out of Specification (OOS) results generated by the Quality Control Laboratory.

Specific instances cited include: 1. **Paremyd (Hydroxyamphetamine HydroBromide and Tropicamide Ophthalmic Solution) lot OF40A (7/2010 release testing):** All four initial Tropicamide Assay results (94.8, 94.6, 94.8, 94.7%) failed to meet release specifications. Re-injection and five new sample preparations confirmed OOS results. The QC laboratory then changed analytical testing procedures (increased standard weight, increased sample pipetting volume, used a newer HPLC system). Five new sample preparations with these changes yielded in-specification results (mean 96.2%). The OOS results were invalidated, and the lot was released, despite the original method being validated for over 10 years, the changes not being validated