National Biological Corporation – FDA Warning Letter, Feb 27, 2008

On January 14-February 27, 2008, an FDA inspection of National Biological Corporation, a manufacturer of UV phototherapy systems, revealed adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Violations included: 1. Failure to document reasons for not investigating complaints (21 C.F.R. § 820.198(b)). 2. Incomplete complaint handling procedures, lacking trending codes and explanations for non-investigated failure codes (21 C.F.R. § 820.198(b)). 3. Incomplete complaint files, missing sections, signatures, and closure dates (21 C.F.R. § 820.198(a)). 4. Failure to evaluate complaints for Medical Device Reporting (MDR) requirements (21 C.F.R. § 820.198(a)(3)). 5. Failure to document Corrective and Preventive Action (CAPA) activities, including root cause analysis and timelines, for nonconforming products and quality issues (21 C.F.R. § 820