Life Recovery Systems HD, LLC

FDA inspection history across 2 sites, 2010 to 2026

2
Warning letters
1
Form 483
1
Close-out

Every document, by year

  • Form 483
  • Warning letter
  • Close-out

2010: one close-out letter and one warning letter; 2012: one warning letter; 2026: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2010–12Two warning letters and one close-out letter, at Kinnelon, New Jersey.
  2. 2026One Form 483, at New Jersey.

Cited most

Across all Life Recovery Systems HD observations on file

  • ISO 13485:2016 Clause 7.1
    Scope
    1
  • ISO 13485:2016 Clause 7.4.3
    1

The complete Life Recovery Systems HD file.

All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$396

The price of the documents, added to your cart together

Sites

Also: two documents not tied to a site.

Documents

4 on file, newest first
DateDocumentPrice
2026-02-05483 Form 483$99
2012-02-23Warning letter Warning letter$99
2010-07-28Close-out Close-out letter$99
2010-07-28Warning letter Warning letter$99

Investigators on these documents

Jaro P. Perera (1)

FEI number 3006059109 · most recent document Feb 5, 2026

About Life Recovery Systems HD, LLC

How many FDA Form 483s has Life Recovery Systems HD, LLC received?

FDA Intel has 1 Form 483 on file for Life Recovery Systems HD, LLC; the most recent is dated Feb 5, 2026.

When was Life Recovery Systems HD, LLC last inspected by FDA?

The most recent FDA inspection document on file for Life Recovery Systems HD, LLC is a Form 483 dated Feb 5, 2026, for the site in New Jersey.

What did FDA cite at Life Recovery Systems HD, LLC?

The regulations cited most in the observations on file for Life Recovery Systems HD, LLC are ISO 13485:2016 Clause 7.1 (Scope), 1 time; ISO 13485:2016 Clause 7.4.3, 1 time.

Has Life Recovery Systems HD, LLC received an FDA warning letter?

Yes. FDA Intel has 2 FDA warning letters on file for Life Recovery Systems HD, LLC; the most recent is dated Feb 23, 2012.