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

On September 27, 2018, the FDA issued a Form 483 to Curexa, a producer of sterile and non-sterile prescription drugs located at 3007 Ocean Heights Ave., Egg Harbor, New Jersey. The inspection, conducted from August 27-30, 2018, and September 13, 25, and 27, 2018, identified deficiencies in the facility's sterile injectable liquid dosage form preparation.

The primary observation noted was that procedures designed to prevent microbiological contamination of purportedly sterile drug products were not established, written, or followed. Specifically, records demonstrating that the cleanroom met the required grade for sterile filling were inadequate. Examples cited include:

* Air changes reported by the contracted service provider did not meet ISO 5 and ISO 6 standards. * Despite the use of magnehelic gauges in the sterile processing suite, no records demonstrated that differential pressure conditions suitable for ISO 5, ISO 6, and ISO 7 were maintained during sterile filling. * Environmental monitoring records lacked continual sampling of non-viable particles to confirm that rooms/hoods classified as ISO 5, ISO 6, or ISO 7 maintained acceptable conditions for intended operations.

The report was issued to Mr. Mark Taylor, RPh, FACVP, Chief Executive Officer.