FDA 483 - Specialty Process Labs LLC - January 26, 2024
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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.
ID · 1436f938-c6a5-4346-9eef-306ff096cd13