Overview
- 14 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-21.
At a glance
Inspections
14
Form 483s
5
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2024 – 21 May 2024 | Biologics | Clean | |
| 4 Feb 2020 – 20 Feb 2020 | Biologics | Clean | |
| 14 May 2019 – 14 Jun 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Jan 2019 – 10 Jan 2019 | Medical Devices & Rad Health | 483 | On file |
| 31 Aug 2017 – 27 Sep 2017 | Biologics | Clean | |
| 8 Aug 2017 – 25 Aug 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 May 2016 – 21 Jun 2016 | Medical Devices & Rad Health | Clean | |
| 6 May 2015 – 14 May 2015 | Biologics | Clean | |
| 5 Sep 2013 – 16 Sep 2013 | Medical Devices & Rad Health | Clean | |
| 15 Aug 2011 | Not recorded | Clean | |
| 12 Nov 2010 | Not recorded | WL | On file |
| 19 Nov 2009 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Jun 2019
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Frank J Marciniak
14 Jun 2019
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Frank J Marciniak
14 Jun 2019
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Frank J Marciniak
Investigators
FDA investigators tied to this site in the record.
Sarah M Forney7 insp.
Frank J Marciniak2 insp.
Esteban Beltran2 insp.
Jennifer A Bazergui2 insp.
Jennifer Macmillan2 insp.
Christopher J Adams1 insp.
Kish Bolden1 insp.
Emily A Walters1 insp.
Jennifer L Custodio1 insp.
MDSAP harperd1 insp.
Denise M Visco1 insp.
Dawn L Wydner1 insp.
Kelli F Dobilas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind LifeCell Corporation's 5 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