FDA WARNING_LETTER - REMINGTON MEDICAL, S.A. - August 14, 2014

On November 28, 2014, the FDA issued a Warning Letter to Remington Medical, S.A., following an inspection from August 11-14, 2014, in Santo Domingo Este, Dominican Republic. The inspection found that the firm's sterile electrode cables, aspiration/injection needles, and cable components for implantable spinal stimulators were adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

The firm's August 28, 2014, response to the FDA 483 was reviewed, but subsequent responses were not. Violations included: 1. Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)), specifically regarding a stylet mix-up (CAPA 14-001) where production personnel were not trained, and the firm did not re-evaluate the CAPA or perform a retrospective review under new requirements. 2. Failure to evaluate and select suppliers based on their ability to meet requirements (21 CFR 820.50(a)(1)), as the firm's purchasing procedure did not require evidence of supplier capability, and a cleanroom certification vendor was not evaluated. The firm did not review existing vendors. 3.