FDA WARNING_LETTER - Digitimer Ltd. - July 02, 2015

On October 19, 2015, the FDA issued a Warning Letter to Digitimer Ltd. following an inspection from June 29 to July 2, 2015. The inspection revealed that Digitimer Ltd., a manufacturer of evoked response electrical stimulators, was not in conformity with the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Failure to control nonconforming product (21 CFR 820.90(a)):** Five of eleven Device History Records showed nonconforming devices distributed without justification (e.g., incorrect resistance/pulse width values). The firm's response was inadequate as it lacked justification for sample size and proof of conformity for previously released products. 2. **Inadequate design change procedures (21 CFR 820.30(i)):** A design change for packaging material lacked a completed Engineering Change Request form, and no verification/validation was performed. The firm's response was insufficient, lacking documentation of packaging tests, protocols, or validation reports. 3. **Failure to control environmental conditions (21 CFR 820.70(c)):** Electrostatic sensitive printed circuit boards were stored outside anti-static containers. The firm's response was inadequate, as it did not include new work instructions for a static