Inovo, Inc – FDA Warning Letter, Nov 19, 2014

On February 19, 2015, the FDA issued a Warning Letter to Inovo, Inc. following a November 17-19, 2014 inspection. The inspection revealed that Inovo's oxygen conservers and regulators, 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 include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)):** Inovo did not determine the root cause or initiate adequate corrective actions for pulse malfunction complaints, which could lead to hypoxemia. Their CAPA process also lacked verification/validation requirements, and they failed to verify the effectiveness of a supplier's corrective action for nonconforming material. Inovo's responses were deemed inadequate, lacking supporting documentation for timely CAPA and implementation of amended procedures. 2. **Failure to control environmental conditions (21 CFR 820.70(c)):** No written justification for the absence of an electrostatic discharge reduction procedure was provided. Inovo's responses were inadequate, showing only drafted documents and no provisions for employee training on new work instructions. 3. **Failure to control purchased product and services (21 CFR 82