FDA WARNING_LETTER - National Biological Corporation - February 27, 2008
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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
ID · 00356106-d250-426f-8c08-387de44be537
Full citation text and observation details available on the Dashboard.