FDA WARNING_LETTER - Perma Pure LLC - August 23, 2010

This FDA Warning Letter, dated October 26, 2011, addresses Perma Pure LLC, a manufacturer of moisture exchange gas dryers, classified as medical devices. An inspection from August 11-23, 2010, revealed that the devices 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.

The letter details ten significant violations, many of which were repeat observations from a July 2006 inspection, indicating a failure to implement previously committed corrective actions. Key deficiencies include:

1. **Management Review (21 CFR 820.20(c)):** Failure of executive management to adequately review the quality system's suitability and effectiveness, as evidenced by seven of eight prior deficiencies remaining uncorrected. 2. **Process Validation (21 CFR 820.75(c)):** Failure to revalidate a process (Nafion tubing conversion) after changes, despite customer notification in 2006. 3. **Software Validation (21 CFR 820.70(i)):** The (b)(4) Calibration Management software, used for calibration records, was not validated. 4. **Equipment Calibration (21 CFR