F.P. Rubinstein Y Cia SRL – FDA Warning Letter, Oct 17, 2014

On January 29, 2015, the FDA issued a Warning Letter to F.P. Rubinstein Y Cia SRL following an inspection from October 14-17, 2014. The firm manufactures dermabrasion, hair removal, radiofrequency skin lifting, and ultrasonic dermal peeling devices, which are considered adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

The letter details eight violations, with the firm's November 7, 2014, response deemed inadequate for most. Key deficiencies include: 1. **Design Control (21 CFR 820.30(e)):** Failure to establish and maintain design review procedures and document reviews for devices like the RC Six Power Basic. 2. **Nonconforming Product (21 CFR 820.90(a)):** Failure to control nonconforming product, specifically not evaluating nine nonconformance reports. 3. **Complaint Handling (21 CFR 820.198(a)):** Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, including not determining reportability under 21 CFR 803, not investigating specific complaints, and inadequate record-keeping. 4. **Design Changes (21 CFR