What Quality System regulation deficiencies have been identified at Abbott’s manufacturing facilities?
FDA has conducted numerous GMP/QS regulation inspections at Abbott’s primary IVD manufacturing locations in Abbott Park and North Chicago (K2 facility), IL. The most recent FDA inspection concluded on July 8, 1999. These inspections showed non-compliance with GMP/QS regulation requirements involving process validation, corrective and preventative action, and production and process controls, among others. 3. What is process validation? Process validation establishes, by objective evidence, that a process (e.g., manufacturing) will consistently produce a product that meets its predetermined specifications. One of the areas of non-compliance identified during inspections at Abbott was process validation. Some manufacturing processes require additional assurances and measures to ensure they consistently result in product that meets predetermined specifications. These additional assurances are necessary because these manufacturing processes cannot be fully verified by subsequent inspection
