FDA WARNING_LETTER - Medica-Rents Co., Ltd. - October 25, 2011

On October 18-25, 2011, an FDA inspection of Medica-Rents Co., Ltd. in Fort Worth, Texas, revealed that their Prospera® PRO-II and III® Negative Pressure Wound Therapy (NPWT) Pump Systems are adulterated. The firm imports, markets, repairs, and performs finished device acceptance testing on these devices. The inspection found the firm's manufacturing, packing, storage, or installation methods and controls non-conformant with the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. **Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a)):** 40 out of 44 returned devices with defects were not reviewed, evaluated, or investigated per the firm's SOPs. The firm's response was partially adequate, lacking explanation on notifying the foreign manufacturer and training distributors. 2. **Failure to maintain a device master record (DMR) (21 CFR 820.181):** Applicable DMR portions for Pro I, II, and III pumps, including repair and servicing procedures for components like circuit boards and motors, were not maintained. Verbal instructions from the foreign manufacturer were not documented. The provided service manual for Pro-III was for a different model. 3. **Failure to establish and maintain adequate finished device acceptance procedures (