FDA EIR - Solvay USA Inc - November 13, 2015

An FDA routine surveillance cGMP inspection of Solvay USA Inc., a non-sterile Active Pharmaceutical Ingredient (API) manufacturer in Spartanburg, SC, was conducted from November 9-13, 2015. The inspection, carried out under Compliance Program 7356.002F for API process inspection, identified eight significant objectionable conditions. Main violations included the firm's failure to perform identity testing of its API starting material and to demonstrate the suitability of process water used in manufacturing. Furthermore, issues were noted with data integrity and access control: label issuance software access was not limited to authorized personnel, and computerized systems for analytical instruments lacked sufficient controls, such as unique login credentials. The company also failed to conduct stability testing for all market containers, such as glass jars used by repackaging contractors, and did not support all listed storage conditions on product labels. Deficiencies in documentation were observed, specifically the lack of recorded completion for critical steps in batch production records, such as cleaning and inspection of drumming equipment. Lastly, Solvay USA Inc. had not established a formal quality agreement with its API repackaging contractor or developed procedures for the evaluation and disposal of expired API products and retain samples. At the inspection's conclusion, Solvay USA Inc. management received a Form FDA 483 detailing these observations and committed to submitting a written response within 15 business days. The management also agreed to address specific issues, including revising cleaning protocols, updating product labels with accurate storage conditions, and investigating improved access controls for computerized systems.