# FDA 483 - Life Recovery Systems HD, LLC - October 21, 2019

Source: https://www.keypedia.com/records/483/life-recovery-systems-hd-llc/f869d823-8b3a-4217-a86b-e54e35e1bb1c

> FDA 483 for Life Recovery Systems HD, LLC on October 21, 2019. 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: 2019-10-21
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Life Recovery Systems HD, LLC, a medical device manufacturer in Kinnelon, NJ, revealed two significant observations. The firm failed to establish adequate procedures for the rework of nonconforming products, specifically regarding O-ring components in Thermosuit Disposable Kits. Additionally, the company did not properly investigate complaints involving potential device failures, lacking sufficient rationale for not conducting investigations.

## 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 - 2023-09-11](https://www.keypedia.com/records/483/life-recovery-systems-hd-llc/b0684ac9-1a1b-4941-8081-dff40761af1b)

## Related Officers

- [Diane B. Radice](https://www.keypedia.com/people/diane-b-radice/46e5716d-4f87-44e5-8b8b-83760f0d1c09)
- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

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