FDA Inspection
Life Recovery Systems HD, LLCLife Recovery Systems HD, LLC – FDA Inspection, Feb 5, 2026
Record Details
This FDA Inspection record concerns Life Recovery Systems HD, LLC, with an inspection on February 5, 2026, issued by the New Jersey District Office, covering medical devices & rad health.
- Inspection Date
- February 5, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 70ec45e6-d6e3-41f4-b411-f76d7e749bdf
Inspection Facts
- Inspection number
- 1302344
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities are inadequate
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Other FDA inspections of Life Recovery Systems HD, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 21, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 14, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 4, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Life Recovery Systems HD, LLC
- FDA Inspection 1218858 - 2023-09-11
- FDA Inspection 1106961 - 2019-10-21
- FDA Inspection 969065 - 2016-03-14
- FDA Inspection 794489 - 2012-08-14
- FDA Inspection 761055 - 2012-01-04
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