FDA WARNING_LETTER - Medical Device Resource Corporation

On September 20, 2013, the FDA issued a Warning Letter to Medical Device Resource Corporation following an inspection from March 5 to May 6, 2013. The inspection revealed that the firm's Aquavage models (AV1200, AV2000, AV3000), LS2 Aspirator, and K Pump devices were adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm's May 28, 2013, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Process Validation (21 CFR 820.75(a)):** Failure to validate heat sealing and e-beam sterilization processes for new sterile barrier pouches and components for Aquavage devices. Previous validations lacked sufficient data, documentation, and defined parameters. 2. **Purchasing Controls (21 CFR 820.50):** Inadequate supplier evaluation records, lack of documented specified requirements for purchased products (vacuum pumps, motor mufflers, vacuum gauges), and absence of systems for supplier change notification. The sterilization contractor was not properly evaluated. 3. **Nonconforming Product (21 CFR