FDA WARNING_LETTER - Simply Clean Air & Water Inc. - July 18, 2014

On August 18, 2014, the FDA issued a Warning Letter to Simply Clean Air & Water Inc. following an inspection from July 9-18, 2014. The inspection revealed that the firm's Portable Exchange Deionization (PEDI) systems, classified as medical devices, 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and maintain design validation procedures (21 CFR 820.30(g))**: PEDI systems for hemodialysis were labeled to an outdated standard (ANSI/AAMI RD62:2001), lacking documentation of testing to the current standard or any design control procedures. 2. **Failure to establish and maintain procedures for acceptance activities (21 CFR 820.80(a))**: No inspection, test, or acceptance criteria existed for manufacturing materials, with incoming components placed directly into inventory. 3. **Failure to establish and maintain procedures for purchased products (21 CFR 820.50)**: The firm lacked supplier qualification forms and records of inspection/testing for incoming materials. 4. **Failure to maintain a device history record (DHR) (21 CFR 82