FDA 483 - Curexa - East, LLC dba Curexa - September 27, 2018

On September 27, 2018, the FDA issued a Form 483 to Curexa, located at 3007 Ocean Heights Ave., Egg Harbor, New Jersey 08234, following inspections conducted from August 27-30, September 13, 25, and 27, 2018. The firm is identified as a producer of sterile and non-sterile prescription drugs. The report was issued to Mr. Mark Taylor, RPh, FACVP, Chief Executive Officer.

The primary observation noted was that procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, or followed, specifically concerning sterile, injectable liquid dosage form preparation.

Deficiencies in cleanroom maintenance and monitoring include: * Records to demonstrate the cleanroom meets the required grade suitable for sterile filling are inadequate. * Air changes reported by the contracted service provider do not meet ISO 5 and ISO 6 standards. * Despite the use of magnehelic gauges in the sterile processing suite, no records demonstrate that differential pressure conditions suitable for ISO 5, ISO 6, and ISO 7 are maintained during sterile filling. * Environmental monitoring records lack continual sampling of non-viable particles to show that rooms/hoods classified as ISO 5, ISO 6, or ISO 7 maintain acceptable conditions for intended operations.