FDA WARNING_LETTER - Laboratorios Dentales De Zona Franca, S.A. - January 30, 2020

On May 15, 2020, the FDA issued a Warning Letter to Laboratorios Dentales De Zona Franca, S.A. following an inspection from January 27-30, 2020, in Cartago, Costa Rica. The inspection revealed that the firm's nightguards, classified as devices, were adulterated under 21 U.S.C. §351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Nonconforming Product Control (21 CFR 820.90(a)):** The firm released nonconforming nightguards (e.g., discolored material) and failed to investigate in-process nonconformances. The firm's response to update procedures and conduct training by April 20, 2020, was deemed inadequate without provided documentation. 2. **Process Validation (21 CFR 820.75(a)):** The firm had not validated manufacturing processes, including software for modeling and the disinfectant step. The firm's response to establish validation procedures and complete actions by May 31, 2020, lacked documentation. 3. **CAPA Procedures (21 CFR 820.100(a)):** The firm failed to initiate CAPAs for identified deficiencies