FDA 483 - SHL Pharma LLC - July 11, 2019

An FDA inspection of GTT Pharma, LLC in Deerfield Beach, FL, revealed significant deficiencies in their quality system, specifically regarding the investigation of out-of-specification (OOS) results. The firm failed to adequately document conclusions and implement corrective and preventative actions for multiple OOS investigations related to drug product stability testing, leading to continued failures. This indicates a breakdown in their quality control processes for handling product deviations.