FDA 483 - Akom Pharmaceuticals, Inc. - April 26, 2017

On May 3, 2017, the FDA issued a Form 483 to Akorn, Inc., a drug manufacturer located at 1222 W Grand Ave, Decatur, IL, following an inspection conducted from April 20-26, 2017. The inspection revealed three observations.

**Observation 1:** The quality control unit's responsibilities and procedures were not in writing and fully followed. Specifically, on April 20, 2017, particles were observed coming off a conveyor belt staging previously washed vials for entry into the filling room. Despite being notified, the firm did not correct the issue before releasing the vial line to manufacture Labetalol HCl 5mg/mL (40 mL) lot 041417 and subsequently Labetalol HCl 5 mg/mL (20 mL) lot 041227.

**Observation 2:** Equipment used in manufacturing was not of appropriate design for its intended use, cleaning, and maintenance. The conveyor belt, used to stage vials, was observed shedding numerous particles of the same color as the belt, varying in size and accumulating at both ends. This issue was noted on April 20, 2017. A list of 76 sterile drug product lots, including AK-FLUOR, MEIHYUNE BLUE, LEVOFLOXACIN, and LABETALOL