Patheon Puerto Rico, Inc. – FDA 483, May 31, 2018

An FDA inspection of Patheon Puerto Rico, Inc., a drug product manufacturer in Manati, PR, revealed significant deficiencies in their quality control systems. The firm failed to thoroughly investigate out-of-specification results with scientific rationale and lacked adequate laboratory controls to ensure accurate test results. Additionally, the inspection found that unlabeled drug product containers were mishandled, leading to multiple consumer complaints about missing lot numbers and expiration dates on distributed products.