FDA 483 - Patheon Puerto Rico, Inc. - October 15, 2019

Patheon part of Thermo Fisher in Manati, PR, was inspected from October 1-15, 2019, and received a Form 483 with two observations. The firm failed to thoroughly review unexplained discrepancies related to Levothyroxine Sodium Tablets and did not follow established production and process control procedures for Janumet Tablets. These issues indicate deficiencies in quality system and production control functions.