FDA WARNING_LETTER - Airsep Corporation - June 19, 2008

On June 26, 2008, the FDA issued a Warning Letter to AirSep Corporation following an inspection from June 6-19, 2008, which found their portable oxygen generators to be adulterated and misbranded. The devices were deemed 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). They were also misbranded under 21 U.S.C. 352(t)(2) for failing to furnish material information required by the Medical Device Reporting (MDR) regulation (21 CFR Part 803).

Key violations include: 1. **Failure to establish and maintain adequate complaint procedures (21 CFR § 820.198(a))**: Procedures did not ensure uniform and timely processing, documentation of oral complaints, or evaluation for MDR reporting, especially for unreturned devices. Specific complaints (CC08D-04, CC05I-83) involving patient deaths with unreturned units lacked documentation of MDR evaluation. 2. **Failure to review and evaluate all complaints for investigation necessity (21 CFR § 820.198(b))**: Several complaints (CC08D-04, CC07