Smithfield Bioscience Inc – FDA EIR, Jul 15, 2022

An FDA for-cause inspection of Smithfield Bioscience Inc. in Cincinnati, OH, was conducted from July 11 to July 15, 2022. The company manufactures Heparin Sodium, USP, and Heparin Lithium, used in medical and diagnostic devices. This inspection followed up on a May 2019 inspection that cited the firm for failing to investigate out-of-specification (OOS) results. The current inspection revealed a repeat observation regarding the inadequate investigation of OOS results, indicating a persistent issue with the company's quality system. Additionally, the FDA issued a three-item Form 483, highlighting further non-compliance with manufacturing standards. Specific violations included the failure to ensure environmental monitoring accurately reflects the production environment and the failure to properly qualify third-party testing laboratories before using them for testing. These observations suggest deficiencies in the firm's adherence to Good Manufacturing Practices. Director of Quality, Mr. David C. Hufnagle, committed to implementing corrective actions and providing a written response to the FDA within 15 business days. The repeated observation emphasizes the need for significant improvements in the company's quality control processes and compliance with regulatory expectations.