Bob@PharmacyExpertWitness.com

PHARMACEUTICAL MANUFACTURING PROCESS

A pharmaceutical manufacturers and medical device manufacturers are required by law to produce drugs and devices in compliance with the Current Good Manufacturing Practices (cGMP).  

The FDA will inspect a facility to assure compliance.   Compliance is not optional, it's the law.  FDA evaluates product for conformance to cGMPs by conducting periodic inspections of facilities and by testing samples. These inspections are conducted at firms in both the U.S. and overseas that sell products in the U.S.

FDA action for non-compliance:

                    Monetary fine

                    Product Recall

                    Warning Letter

                    License Suspension or Revocation

                    Product Seizure

                    Criminal Prosecution

See Able Pharmaceutical's (a former generic drug manufacturer) literally got shut down by FDA and had a total product line recall.   One particular medicine that was recalled was a nitroglycerin pill to prevent a heart attack.  Presently, the company is not producing any drugs and is Chapter 11 Bankruptcy.

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