# FDA WARNING_LETTER - Lifewatch Services, Inc. - September 14, 2012

Source: https://www.keypedia.com/records/warning_letter/lifewatch-services-inc/d66eaa37-b7cc-4fb2-a51a-150ea49e08c2

> FDA WARNING_LETTER for Lifewatch Services, Inc. on September 14, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lifewatch Services, Inc.
- Inspection Date: 2012-09-14
- Product Type: Devices
- Office Name: Chicago District Office
- Summary: 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

## Related Officers

- [Scott J. Macintire](https://www.keypedia.com/people/scott-j-macintire/ca3dc0d0-ffd3-4d61-bd98-56aa7d8b15af)

Company: https://www.keypedia.com/companies/lifewatch-services-inc/3d695e38-3c23-4b1d-84da-2a5825ed1386

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669