# FDA 483 - Life Recovery Systems HD, LLC - February 05, 2026

Source: https://www.keypedia.com/records/483/life-recovery-systems-hd-llc/852e668c-ee39-4301-88c3-705398207161

> FDA 483 for Life Recovery Systems HD, LLC on February 05, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Life Recovery Systems HD, LLC
- Inspection Date: 2026-02-05
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Life Recovery Systems HD, LLC, a medical device manufacturer in Kinnelon, NJ, received a Form 483 with two observations. The inspection revealed deficiencies in the firm's risk management processes for its ThermoSuit device, indicating inadequate documentation and implementation. Additionally, the firm's verification activities for purchased temperature monitoring probes were found to be insufficient, lacking proper accuracy evaluations.

## Related Documents

- [WARNING_LETTER - 2012-01-04](https://www.keypedia.com/records/warning_letter/life-recovery-systems-hd-llc/bef67bd6-6b4f-4871-88c8-887e16d26c9a)
- [483 - 2019-10-21](https://www.keypedia.com/records/483/life-recovery-systems-hd-llc/f869d823-8b3a-4217-a86b-e54e35e1bb1c)
- [483 - 2023-09-11](https://www.keypedia.com/records/483/life-recovery-systems-hd-llc/b0684ac9-1a1b-4941-8081-dff40761af1b)

## Related Officers

- [Jaro P. Perera](https://www.keypedia.com/people/jaro-p-perera/5555676c-2151-4ecd-bad8-72a1ddab8936)

Company: https://www.keypedia.com/companies/life-recovery-systems-hd-llc/2fd26805-2b41-46a3-9364-a6405fd99348

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248