# FDA WARNING_LETTER - F.P. Rubinstein Y Cia SRL - October 17, 2014

Source: https://www.keypedia.com/records/warning_letter/fp-rubinstein-y-cia-srl/2ae119e6-1db7-402c-a590-6ce10001660e

> FDA WARNING_LETTER for F.P. Rubinstein Y Cia SRL on October 17, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: F.P. Rubinstein Y Cia SRL
- Inspection Date: 2014-10-17
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Jan B. Welch](https://www.keypedia.com/people/jan-b-welch/65bfaf7c-7ce6-4c33-80bd-090efbf2eec5)
- [Agustin Caunedo](https://www.keypedia.com/people/agustin-caunedo/ee2b7ba0-be06-481e-ba48-414beb680d5b)

Company: https://www.keypedia.com/companies/fp-rubinstein-y-cia-srl/60695a1e-99d6-409c-a053-c2742bd064ee

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7