FDA WARNING_LETTER - Nexera Medical, Inc. - July 31, 2012

On October 16, 2012, the FDA issued a Warning Letter to Nexera Medical, Inc. following an inspection from July 30-31, 2012, which found their SpectraShield™ 9500 Surgical N95 Respirator to be adulterated and misbranded.

The device was deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations included: 1. **Failure to establish and maintain adequate procedures for validating device design (21 CFR 820.30(g))**: The firm's procedure lacked design validation provisions, and no design validation, including risk analysis, was documented for the SpectraShield™ 9500. The provided response was inadequate. 2. **Failure to establish and maintain procedures for implementing corrective and preventive actions (CAPA) (21 CFR 820.100(a) and (b))**: No CAPA procedures existed, and investigations or effectiveness checks for previous corrections were not documented. The response was inadequate, as the provided procedure did not define the process for elevating nonconformities to CAPAs. 3. **Failure to establish and maintain procedures to ensure purchased products and services conform to requirements (21 CFR 820.