FDA 483 - Pfizer, Inc. - June 07, 2017

Pfizer, Inc. in Groton, CT, a Control Testing Laboratory, was cited with four observations during an FDA inspection. The observations highlight significant deficiencies in laboratory control mechanisms, including incomplete investigations of discrepancies, lack of standard operating procedures for HPLC column maintenance, and inadequate method transfer assessments for compendial methods. Additionally, the Quality Unit's responsibilities were found to be insufficiently documented and followed, impacting overall quality oversight.