FDA 483 - Viatris Pharmaceuticals LLC - December 20, 2019

This FDA Form 483 was issued to PFIZER PHARMACEUTICALS LLC in Barceloneta, Puerto Rico, a manufacturer of API and drug products. The inspection revealed significant deficiencies in the quality control unit's investigation processes, ineffective implementation of corrective and preventive actions, and incomplete batch production and control records. These observations indicate a lack of adherence to established procedures and proper documentation practices.