FDA WARNING_LETTER - MP Biomedicals LLC - April 22, 2010

On March 29-April 22, 2010, an FDA inspection of MP Biomedicals Diagnostic Division, a manufacturer of in-vitro diagnostic (IVD) kits, revealed significant violations of Current Good Manufacturing Practice (CGMP) and Quality System (QS) regulations (21 CFR Part 820), rendering their devices adulterated under 21 U.S.C. § 351(h).

Key violations include: 1. **Failure to validate processes (21 CFR § 820.75(a)):** The firm did not validate the foil bag sealing, mixing, filling, plate/tube coating, cleaning, and lyophilization processes for IVD kit components. The ACTH test kit validation report showed 70 out of 142 out-of-specification results that were not addressed. 2. **Inadequate finished device acceptance procedures (21 CFR § 820.80(d)):** "ELISA MATERIAL SPECIFICATION" procedures allowed averaging or removal of out-of-specification (OOS) values during finished device testing, without failure investigations or statistical justification. For example, 17 of 30 Phenylalanine Kits had OOS values. Calibrator data points were routinely removed without documentation or justification (e.g., 11 points from one lot, 2 from another). 3. **Failure to evaluate