FDA 483 - Catalent Pharma Solutions, LLC - February 22, 2019

An FDA inspection of Catalent Pharma Solutions, LLC in Saint Petersburg, FL, revealed significant deficiencies across their laboratory and production systems. The firm failed to adhere to its written stability testing program, utilized an inadequate dissolution test method for a drug product, and did not follow or properly document written production and process control procedures. These issues indicate a lack of adherence to established quality and manufacturing standards.