Life Recovery Systems HD, LLC
Form 483 issued February 5, 2026 · New Jersey
- Inspection
- Feb 2 – Feb 5, 2026
- Investigator
- Jaro P. Perera
- Observations
- 2
- Pages
- 5
- FEI number
- 3006059109
In short: On February 5, 2026, FDA issued a Form 483 with 2 observations to Life Recovery Systems HD, LLC in New Jersey (FEI 3006059109) after an inspection that ran Feb 2 – Feb 5, 2026. The investigator was Jaro P. Perera. The most-cited regulation is 21 CFR 7.1 (scope).
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.1
One or more processes for risk management in product realization have…
- 02ISO 13485:2016 Clause 7.4.3
The extent of verification activities for purchased product was not proportionate to the risks associated…
This inspection in context
Jaro P. Perera
1 document · 2026
Cites ISO 13485:2016 Clause 7.1 (scope) more than any other section. Most of their documents are for sites in New Jersey.
The firmLife Recovery Systems HD, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Life Recovery Systems HD, LLC?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 7.1 (scope). The opening words of each observation are shown on this page.
Who inspected Life Recovery Systems HD, LLC?
Jaro P. Perera is named on this Form 483, for the inspection of Feb 2 – Feb 5, 2026. Each investigator has a profile showing what they cite most.
When was Life Recovery Systems HD, LLC inspected by FDA?
The inspection ran Feb 2 – Feb 5, 2026, and the Form 483 is dated February 5, 2026.
How do I get the full Form 483 for Life Recovery Systems HD, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.