FDA 483 - Porton Pharma Solutions Ltd - November 19, 2018

Porton Pharma Solutions Ltd., an API manufacturer in Changshou, China, was cited for significant deficiencies in its quality control unit, laboratory oversight, and data integrity practices. Observations included incomplete and non-contemporaneous cGMP training records, a lack of an adequate data integrity program for electronic laboratory systems, and insufficient investigation and documentation of unexplained discrepancies in analytical testing. These issues indicate a systemic failure to ensure data reliability and adherence to quality control procedures.