FDA WARNING_LETTER - Go Medical Industries Pty., Ltd. - September 14, 2011

On December 23, 2012, the FDA issued a Warning Letter to Go Medical Industries Pty., Ltd. following an inspection from September 12-14, 2011, at their Subiaco, Australia facility. The inspection found that the firm's flow control tubing, infusion pumps, and urological catheters are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Specific violations include: 1. Failure to validate processes where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), evidenced by the lack of procedures for a (b)(4) study for catheters and catheter kits. 2. Failure to establish and maintain adequate procedures to control nonconforming product (21 CFR 820.90(a)), as the firm did not monitor or act on bioburden data exceeding alert limits for private customer products manufactured at the same contract facility as Go Medical devices.

Additionally, the firm's Flow Control Tubing is misbranded under 21 U.S.C. § 352(t)(2) due to failure to furnish required information under 21 U.S.C. § 360i and