Degania Medical Devices Pvt Ltd. – FDA Warning Letter, Aug 29, 2014

On December 23, 2014, the FDA issued a Warning Letter to Degania Medical Devices Pvt. Ltd. following an inspection from August 25-29, 2014, which found their catheters to be 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. **Failure to validate computer software (21 CFR 820.70(i))**: The firm's operating system for in-process testing (e.g., tensile and sensor testing) was not validated, allowing data manipulation. The firm's response was inadequate as it lacked retrospective review of all software used for device production. 2. **Failure to control nonconforming product (21 CFR 820.90(a))**: Nonconforming products were not properly identified or segregated per SOPs. The firm's response was inadequate, as it did not include a retrospective review of all manufacturing areas for unidentified nonconforming product. 3. **Failure to control documents (21 CFR 820.40)**: The electronic document control system allowed manipulation of SOPs, work instructions, and forms. Multiple versions of forms were in use, and a single username/password accessed label generation. The adequacy