# FDA WARNING_LETTER - Life Force of Tampa, LLC - January 28, 2014

Source: https://www.keypedia.com/records/warning_letter/life-force-of-tampa-llc/fff6118e-be90-43d6-9ec1-d0584634793d

> FDA WARNING_LETTER for Life Force of Tampa, LLC on January 28, 2014. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Life Force of Tampa, LLC
- Inspection Date: 2014-01-28
- Product Type: Devices
- Office Name: Florida District Office
- Summary: On May 21, 2014, the FDA issued a Warning Letter to Life Force of Tampa, LLC, following an inspection from January 27-28, 2014. The inspection revealed that the firm's LIFE FORCE® chamber is a medical device and is adulterated under 21 U.S.C. § 351(h) due to non-conformity with cGMP requirements of 21 CFR Part 820 (Quality System regulation).

Key violations include:
1. Failure to establish and maintain design control procedures (21 CFR § 820.30(a)(1)), lacking documentation for labeling requirements.
2. Failure to establish and maintain corrective and preventive action procedures (21 CFR § 820.100(a)).
3. Failure to establish and maintain complaint handling procedures and files (21 CFR § 820.198(a)).
4. Failure to develop, conduct, control, and monitor production processes to ensure device conformity to specifications (21 CFR § 820.70(a)), with provided procedures lacking adequate instructions and technical specifications.
5. Failure to establish and maintain procedures for acceptance activities, including final inspection and incoming inspection of components (21 CFR § 820.80(a)).

The device is also misbranded under 21 U.S

## Related Officers

- [Elizabeth W. Ormond](https://www.keypedia.com/people/elizabeth-w-ormond/55f8bf5b-dbd6-4cd5-b3de-7606dec3727c)

Company: https://www.keypedia.com/companies/life-force-of-tampa-llc/6663d7d3-cd6b-402a-8eb3-ef5e14a69d54

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9