Richard Wolf Medical Instruments Corp. – FDA Warning Letter, May 8, 2013

An FDA inspection of Richard Wolf Medical Instruments Corporation (RWMIC) in Vernon Hills, Illinois, from March 25 to May 8, 2013, revealed that the firm's flexible/rigid endoscopes (Class II), electrosurgical units and accessories (Class II), and the Hulka fallopian clip applicator (Class III) are adulterated. The methods, facilities, or controls used for their manufacture, processing, packing, or holding do not conform to the Quality System (QS) Regulation (21 CFR Part 820).

Violations include: 1. **Failure to establish complaint handling procedures (21 CFR 820.198(a)):** RWMIC's procedure QA-004 did not ensure appropriate identification and processing of complaints, with 12 of 45 records not handled as complaints. Risk analyses or documented rationales were not provided for non-MDR reportable complaints, and complaints were not forwarded to the manufacturer in a timely manner. RWMIC's responses were inadequate, lacking detail, justification, and proposed revised procedures. 2. **Failure to define control over suppliers (21 CFR 820.50(a)(2)):** Procedure PU-004 and associated forms did not detail or justify supplier designations or how these affect the extent of control. RWMIC's responses were inadequate as revised procedures and forms were