Lifewatch Services, Inc. – FDA Warning Letter, Sep 14, 2012

On September 26, 2016, the FDA issued a Warning Letter to LifeWatch Services, Inc. following an inspection from August 16, 2012, to September 14, 2012. The inspection found that LifeWatch Services, a manufacturer and re-packager/re-labeler of cardiac event monitors (e.g., ACT III, King of Hearts AF), had adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Quality System Regulation (21 CFR Part 820).

Key violations included: 1. **Failure to adequately establish complaint handling procedures (21 CFR 820.198(a))**: Devices returned due to failure were not processed, reviewed, and evaluated uniformly or timely. For example, Complaint #12-058 was received on 12/02/2011 but initiated on 02/08/2012. The firm's proposed 25-day timeframe for MDR evaluation was deemed inadequate for timely reporting. 2. **Failure to investigate complaints involving device failure (21 CFR 820.198(c))**: Returned devices were repaired or scrapped without further investigation into the cause of failure. The firm's responses lacked documentation/justification for attributing failures to wear