Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-07-15.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jul 2022 – 15 Jul 2022 | Biologics | 483 | View 483 → |
| 24 Jul 2019 – 30 Jul 2019 | Biologics | Clean | |
| 9 May 2018 – 11 May 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jan 2017 – 12 Jan 2017 | Biologics | Clean | |
| 9 Feb 2015 – 24 Feb 2015 | Biologics | Clean | |
| 26 Sep 2012 | Not recorded | Clean | |
| 3 Sep 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jul 2022
21 CFR 1271.190(a)
State of repair
Cited by Barbara T Carmichael, Lura D Baquero, Lura D Kelly, Johnathan M Crayton
11 May 2018
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Richard K Vogel
Investigators
FDA investigators tied to this site in the record.
Samantha J Pinizzotto3 insp.
Barbara T Carmichael1 insp.
Lura D Baquero1 insp.
Lura D Kelly1 insp.
Johnathan M Crayton1 insp.
Brentley S Collins1 insp.
Randy L Clarida1 insp.
Richard K Vogel1 insp.
Ivan E Reyes1 insp.
Mizanne E Lewis1 insp.
Jana L Caylor1 insp.
Ronnie E Jackson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.190(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind LifeLink Foundation, Inc.'s 2 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat