FDA 483 - Akom Pharmaceuticals, Inc. - May 16, 2018

This FDA Form 483 was issued to Akorn, Inc., a sterile drug manufacturer located at 1222 W. Grand Ave., Decatur, IL 62522. The inspection occurred from April 9-20, May 3, and May 7-11, 16, 2018. Jonathan D. Shoemaker, Vice President and General Manager, was the recipient of the report.

The inspection revealed several observations:

* **Observation 1:** The firm failed to establish and follow appropriate written procedures to prevent microbiological contamination of sterile drug products, including validation of aseptic and sterilization processes. Specific issues included poor aseptic processing techniques (reaching over open vials, improper intervention execution, non-aseptic stopper addition, touching gowns then stopper bags, and replacing fallen vials). * **Observation 6:** An NDA-Field Alert Report was not submitted within three working days for: * A downward pH trend in Indocyanine Green (NDA no. 11-525) lots (021656, 31206, 041136, 051216, 061486). * Customer complaint investigation (PR # 78593) documenting "some dark spots/mold." * Failure to notify FDA when Acetylcysteine Injection 20