FDA 483 - Specialty Process Labs LLC - January 26, 2024

Specialty Process Labs LLC, an API manufacturer in Phoenix, AZ, was cited for significant deficiencies across its operations. The inspection revealed inadequate validation of manufacturing processes and microbiology lab equipment, a failure to investigate out-of-specification stability results, and insufficient equipment cleaning validation. Furthermore, the firm demonstrated a severe lack of data integrity controls for electronic records and critical quality unit failures, including unclosed CAPAs and unvalidated microbiological testing methods.