FDA WARNING_LETTER - DIMA S.L. - July 03, 2014

On June 30, 2014, through July 3, 2014, the FDA inspected Desarrollo e Investigación Médica Aragonesa (DIMA) S.L. in Calatayud, Zaragoza, Spain, and found that the firm's Anchorsure, Remeex slings, needleless slings, and incontinence mesh devices were adulterated. The manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System regulation (21 CFR Part 820).

Violations included: 1. Failure to control production processes (21 CFR 820.70(a)): No documentation for installation and operational qualification of the LAR 179 CNC machine. 2. Failure to establish change control procedures (21 CFR 820.70(b)): No procedures for changes to specifications, methods, processes, or procedures, and no documentation for verification/validation of a new part installed on a weaving machine. 3. Failure to control environmental conditions (21 CFR 820.70(c)): No environmental control procedures, and clean room ventilation systems were shut down overnight without validation of proper operation after startup. 4. Failure to control design changes and validate designs (21 CFR 820.30(i) and 820.30(g)): No design change procedure, risk analysis not updated