FDA WARNING_LETTER - Invacare Corporation - August 18, 2010

On December 15, 2010, the FDA issued a Warning Letter to Invacare Corporation following an inspection from August 2-18, 2010, at their Sanford, Florida facility, which manufactures manual, electric, and semi-electric beds. The inspection revealed that Invacare's devices are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 C.F.R. Part 820).

Key violations include: 1. **Failure to analyze quality data (21 CFR 820.100(a)(1)):** Invacare failed to adequately analyze MDRs, adverse events, and complaints for trends, especially concerning entrapment and fire hazards. Their CAPA procedure lacked clear requirements for complaint analysis and statistical methodology. 2. **Failure to establish corrective/preventive actions (21 CFR 820.100(a)(3)):** Recurring complaints regarding potential sparks/fires and entrapment (including incidents of death and serious injury) lacked documented corrective and preventive actions. Invacare's response was deemed inadequate as it did not provide evidence of systemic corrective actions. 3. **Inadequate complaint investigation records (21 CFR 820.198(