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FDA: Airsep Employees Lack Adequate GMP Training

January 8, 2010
Airsep’s employees do not have the necessary good manufacturing practice (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