# FDA 483 - Life Recovery Systems HD, LLC - September 11, 2023

Source: https://www.keypedia.com/records/483/life-recovery-systems-hd-llc/b0684ac9-1a1b-4941-8081-dff40761af1b

> FDA 483 for Life Recovery Systems HD, LLC on September 11, 2023. 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: 2023-09-11
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Life Recovery Systems HD, LLC in Kinnelon, NJ, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for verifying the effectiveness of corrective and preventive actions. Additionally, the company did not properly control non-conforming incoming product, as evidenced by a lack of non-conformance reports for rejected materials.

## 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)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/matthew-w-kyle/0f297104-ae6c-4fc4-a240-c84e5e907803)
- [Jonathan Ho](https://www.keypedia.com/people/jonathan-ho/434f1c30-b660-4bc9-bc31-017366282edd)
- [Nakesh N. Gomanie](https://www.keypedia.com/people/nakesh-n-gomanie/cfffa8e1-fdfb-4bc4-a845-44bcd593c9c7)

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