Spartan Chemical Co Inc – FDA 483, Dec 12, 2022

An FDA inspection conducted at Spartan Chemical Co Inc from December 5-12, 2022, identified significant deficiencies in their manufacturing and quality control operations. The FDA Form 483 detailed observations indicating a lack of adequate controls over computer systems used for critical production and quality records. Noted issues included shared user logins for HPLC analysis software, unauthorized personnel's ability to modify testing methods, the use of unvalidated spreadsheets for result calculations, absence of audit trails, and insufficient data backup procedures, impacting ten drug products.

Furthermore, the company could not provide executed performance qualification protocols for bulk drug product formulations, hindering review of essential records. Laboratory controls were deemed inadequate, with unknown peaks in drug product chromatograms not identified, insufficient analysis of forced degradation studies, and an unvalidated method for microbial testing. The firm also accepted component supplier analyses without establishing their reliability or adequately retesting recertified active ingredients. Spartan Chemical Co Inc is expected to implement comprehensive corrective actions to address these observations and ensure compliance with the Federal Food, Drug and Cosmetic Act.