FDA WARNING_LETTER - TZ Medical Inc. - August 25, 2011

The FDA issued a Warning Letter to TZ Medical Inc. following an inspection from August 22-25, 2011, identifying significant violations.

The company is marketing Neptune Products (Neptune Pad, Neptune Comfort-Band, Comfort Band) with unapproved claims, including "Natural Anti-Microbial Barrier" and effects at the femoral artery, which constitute major changes in intended use. These products are deemed adulterated and misbranded because the company lacks required premarket approval (PMA) or investigational device exemption (IDE) and failed to submit a 510(k) notification for the changes.

Additionally, Neptune Plus Pad, Neptune Dot Pad, Hemo, and Hemo II are being sold without any marketing approval or clearance, making them adulterated and misbranded. These products also carry the unapproved antimicrobial barrier and wound healing claims.

The company failed to adequately develop, maintain, and implement written Medical Device Reporting (MDR) Procedures (21 CFR Part 803.17(a)), specifically lacking processes for timely event identification, complete report submission, and correct address for MDR reports. The procedure also incorrectly references baseline reports.

Furthermore, Quality System (QS) regulation violations include failure to control nonconforming product (21 CFR 820.90(a)), with inadequate documentation and evaluation of rejected devices. The company's response to this was deemed inadequate. While the company's response