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GRAM completed a fourth FDA inspection of its parenteral manufacturing facility with no Form 483 observation issues.
Grand River Aseptic Manufacturing (GRAM) announced on Feb. 10, 2016 the competition of its fourth FDA inspection of its contract parenteral manufacturing facility in Grand Rapids, MI.
The seven-day inspection included a general GMP and a pre-approval inspection. FDA found GRAM to be in compliance with the current good manufacturing practices (cGMP) and passed pre-approval inspection, with no Form 483 observation issues. According to FDA, Form 483 is issued at the conclusion of inspections if the investigators discover violations of the Food Drug and Cosmetic Act and related acts.
GRAM is a parenteral contract manufacturing organization focused on cGMP manufacturing and new product development. The company specializes in preclinical, clinical, and commercial manufacturing.