Deymed Diagnostic s.r.o. – FDA Warning Letter, Jul 27, 2023

On November 7, 2023, the FDA issued a Warning Letter to Deymed Diagnostic s.r.o. following an inspection from July 24-27, 2023. The inspection revealed that Class II non-sterile devices, including BrainFeedback Pro, TruScan LT, and contract-manufactured DuoMAG NL, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. **Failure to establish and maintain adequate design control procedures (21 CFR 820.30(a))**: BrainFeedback PRO, shipped to the U.S. since 2015, was not subjected to the design control process. Corrective actions, including a CAPA, procedure revisions, and personnel training, were initiated, and sales of BrainFeedback Pro in the U.S. were discontinued. However, the response was inadequate as the firm had not deleted its GUDID database entry and did not clarify how previously sold devices would be made compliant. 2. **Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a))**: Over 180 U.S. customer complaints since 2019 were not evaluated for Medical Device Report submission or