FDA WARNING_LETTER - Woo Young Medical - September 13, 2012

On September 10-13, 2012, an FDA inspection of Woo Young Medical Co., Ltd. in Jincheon-gun, Korea, revealed that their elastomeric infusion pumps are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) for current good manufacturing practices.

Violations include: 1. **Process Control Procedures (21 CFR 820.70(a)):** No documentation of sterility verification for sterile water used in component washing or for finished devices. The bioburden test procedure lacked negative control incubation. The firm's response was inadequate, lacking sterility testing for lot #CDHAN103 and systemic corrective action evidence. 2. **Finished Device Acceptance (21 CFR 820.80(d)):** No documentation of sterility verification for the finished sterile-labeled device. Sterility test report for lot CDHAN103 lacked documentation of controls for fungi testing. The firm's response was inadequate, lacking sterility testing for lot #CDHAN103 and systemic corrective action evidence. 3. **Software Validation (21 CFR 820.70(i)):** No evidence of validation for the [b][4] software used for flow rate graphic representation, lacking user, input, or output requirements