FDA WARNING_LETTER - National Biological Corp - March 20, 2017

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