# FDA WARNING_LETTER - National Biological Corporation - February 27, 2008

Source: https://www.keypedia.com/records/warning_letter/national-biological-corporation/00356106-d250-426f-8c08-387de44be537

> FDA WARNING_LETTER for National Biological Corporation on February 27, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: National Biological Corporation
- Inspection Date: 2008-02-27
- Product Type: Devices
- Office Name: Cincinnati District Office
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/carol-a-heppe/a057476d-74dd-4a29-9f11-6da6fd9ed70d)

Company: https://www.keypedia.com/companies/national-biological-corporation/b505a9e3-d0c4-402b-a91a-fb19792b3850

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22