FDA WARNING_LETTER - SCM True Air Technologies LLC - May 24, 2013

On May 6-24, 2013, an FDA inspection of SCM True Air Technologies, Inc. in Louisville, KY, revealed that their bariatric beds and low air loss controllers are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. Failure to control nonconforming product (21 CFR 820.90(a)): Procedures were inadequate, and 34 of 48 nonconforming beds were not evaluated or investigated. 2. Failure to establish complaint handling procedures (21 CFR 820.198(a)): A complaint regarding 48 bariatric beds with defects was not entered into the system. 3. Inadequate design input procedures (21 CFR 820.30(c)): Design procedures lacked defined performance, safety, environmental, and physical characteristics, and were not fully implemented. 4. Inadequate design output procedures (21 CFR 820.30(d)): Procedures lacked acceptance criteria, and design outputs like instructions for use and specifications were incomplete. 5. Failure to verify device design (21 CFR 820.30(f)):