FDA: Airsep Employees Lack Adequate GMP Training

Airsep’s employees do not have the necessary GMP training to perform their jobs, the FDA says in a Form 483.

Although the vice president of resources and regulatory affairs is the management representative to Airsep’s quality system, he has not received ongoing quality training, the FDA found during a Sept. 22 to Oct. 5 inspection.

The form also notes no internal quality audit was conducted to verify effective corrections were made after a previous inspection and a warning letter.
The GMP Letter