FDA Tells Contract Manufacturer to Hire a GMP Consultant

Contract Pharmacal of Hauppauge, N.Y., received an FDA warning letter for manufacturing processes that violated current good manufacturing practice (GMP) regulations and for manufacturing several products without approved applications. After the FDA’s inspection of the company’s facilities, the company did not offer the results of root cause investigations or take adequate corrective actions for metal slivers found compressed in chlorpheniramine maleate 4-mg tablets, the letter said.
Drug GMP Report