Missouri Analytical Laboratories Inc – FDA Warning Letter, May 19, 2021

The FDA issued a Warning Letter to Missouri Analytical Laboratories, Inc. following a May 3-19, 2021 inspection, citing significant violations of CGMP regulations for finished pharmaceuticals (21 CFR parts 210 and 211) and deviations from CGMP for active pharmaceutical ingredients (API). This renders their drugs adulterated.

Key violations include: 1. **Failure to thoroughly investigate discrepancies and OOS results (21 CFR 211.192):** Investigations were inadequate, relying on retesting without identifying root causes. For example, an OOS assay result for (b)(4) was invalidated by retesting fresh samples without a scientific root cause. Additionally, falsification of (b)(4) records (autoclave cycle times) was detected and inadequately investigated for its extent and data integrity implications. 2. **Inadequate control over computer systems (21 CFR 211.68(b)):** The (b)(4) system lacked unique user accounts and privilege levels, allowing analysts to delete/overwrite data, with approximately 36 deleted files found. Non-validated (b)(4) spreadsheets were used for calculations. The firm's response regarding system upgrades and deleted "working copies" was deemed inadequate without a retrospective review or interim controls. 3. **Failure to document and investigate critical API deviations:** Initial OOS (b)(4) results for (