FDA WARNING_LETTER - Tango3 LLC - February 10, 2012

On May 23, 2012, the FDA issued a Warning Letter to Tango3 LLC following an inspection from January 11 to February 10, 2012. The inspection revealed that the Tango3 water storage tank with ozone disinfection system is an adulterated device under 21 U.S.C. § 351(h) because its manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Design Control Deficiencies:** Failure to adequately document design input requirements (21 CFR 820.30(c)), document, review, and approve design outputs (21 CFR 820.30(d)), and perform adequate design validation, including software validation and risk analysis (21 CFR 820.30(g)). The firm also failed to adequately transfer device design into production specifications (21 CFR 820.30(h)). 2. **Nonconformance and Rework:** Failure to control nonconforming product and investigate nonconformances (21 CFR 820.90(a)), and failure to document rework and reevaluation activities in Device History Records (DHR) (21 CFR 820.90(b)(2)). 3. **Incoming and Finished Device Acceptance:**