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

Source: https://www.keypedia.com/records/warning_letter/simply-clean-air-water-inc/02c1f15f-ee33-4951-8e54-a657ad140cc8

> FDA WARNING_LETTER for Simply Clean Air & Water Inc. on July 18, 2014. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Simply Clean Air & Water Inc.
- Inspection Date: 2014-07-18
- Product Type: Devices
- Office Name: New England District Office
- Summary: 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and maintain design validation procedures (21 CFR 820.30(g))**: PEDI systems for hemodialysis were labeled to an outdated standard (ANSI/AAMI RD62:2001), lacking documentation of testing to the current standard or any design control procedures.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

## Related Documents

- [483 - 2022-04-29](https://www.keypedia.com/records/483/simply-clean-air-water-inc/c7d7525f-a49c-4c98-bec5-e6ec68e803d7)

## Related Officers

- [District Director](https://www.keypedia.com/people/mutahar-shamsi/f1ed0c75-3167-41cb-a918-130aa6d0fb07)

Company: https://www.keypedia.com/companies/simply-clean-air-water-inc/cd848506-b3bf-428f-a970-02204a30830e

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144