# FDA WARNING_LETTER - National Biological Corp - March 20, 2017

Source: https://www.globalkeysolutions.net/records/warning_letter/national-biological-corp/73e3630e-9dcd-4460-b5e2-e88faffc0e15

> FDA WARNING_LETTER for National Biological Corp on March 20, 2017. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: National Biological Corp
- Inspection Date: 2017-03-20
- Product Type: Devices
- Office Name: New England District Office
- Summary: On July 11, 2017, the FDA issued a Warning Letter to National Biological Corporation following an inspection from March 6-20, 2017, which found their UV phototherapy systems to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations include:
1.  **Process Validation (21 CFR 820.75(a)):** Failure to validate crimping press/applicator machines and the gluing/curing process for Dermalume 2x devices. The firm's response, proposing validation by June 30, 2017, and April 30, 2018, for other processes, requires an update.
2.  **Nonconforming Product (21 CFR 820.90):** Procedures did not ensure all nonconformances were evaluated for investigation, with 500 nonconformances in 2016 lacking evaluation. Additionally, 14 nonconformances lacked disposition. The firm's proposed 4-month retrospective review was deemed inadequate; a 2-year review is typically expected.
3.  **Complaint Handling (21 CFR 820.198(b)):** Failure to establish procedures for evaluating all complaints

## Related Documents

- [483 - 2020-03-13](https://www.globalkeysolutions.net/records/483/national-biological-corp/7e195170-89aa-41fe-9aa6-903e34acc746)

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/joseph-s-matrisciano/62ff5cd6-c3ab-4443-bf26-f61a512f3960)

Company: https://www.globalkeysolutions.net/companies/national-biological-corp/2ea6c746-7d5e-43ca-bc6f-ced3c21c9311

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144