FDA WARNING_LETTER - Noble Anesthesia-Air, Inc. - June 26, 2012

On September 12, 2012, the FDA issued a Warning Letter to Noble Anesthesia-Air, Inc. following an inspection from June 19-26, 2012. The inspection revealed that the firm's devices, including the Adult SNOR-TAL, SNOR-SCOPE, SNOR-PAC, SNOR-CAL, and SNOR-SCOPE PLUS, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)(1)). 2. Failure to establish and maintain adequate procedures for design input requirements, including review and approval (21 CFR 820.30(c)). 3. Failure to establish and maintain adequate procedures for design verification and documentation in the Design History File (DHF) (21 CFR 820.30(f)). 4. Failure to establish and maintain design validation procedures, including risk analysis and documentation (21 CFR 820.30(g)). 5. Failure to establish and maintain procedures for design transfer to production specifications (21 CFR 820.30(h)). 6.