Overview
- 21 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-13.
At a glance
Inspections
21
Form 483s
6
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Aug 2024 – 13 Aug 2024 | Medical Devices & Rad Health | Clean | |
| 3 Oct 2022 – 14 Oct 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Dec 2018 – 10 Dec 2018 | Medical Devices & Rad Health | Clean | |
| 7 Nov 2017 – 14 Nov 2017 | Biologics | 483 | On file |
| 29 Nov 2016 – 7 Dec 2016 | Medical Devices & Rad Health | Clean | |
| 29 Jun 2016 – 30 Jun 2016 | Medical Devices & Rad Health | Clean | |
| 11 Jan 2016 – 22 Jan 2016 | Biologics | Clean | |
| 8 Apr 2015 – 10 Apr 2015 | Medical Devices & Rad Health | Clean | |
| 2 Dec 2013 – 18 Dec 2013 | Medical Devices & Rad Health | 483 | On file |
| 16 May 2013 – 24 May 2013 | Biologics | 483 | On file |
| 25 Jan 2013 | Not recorded | Clean | |
| 19 Aug 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Oct 2022
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by James R Montero, Jenny L Mccardell, Jenny L Chisem
14 Oct 2022
21 CFR 820.198(e)
Records of complaint investigation
Cited by James R Montero, Jenny L Mccardell, Jenny L Chisem
14 Oct 2022
21 CFR 820.30(g)
Design validation - production units
Cited by James R Montero, Jenny L Mccardell, Jenny L Chisem
14 Oct 2022
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by James R Montero, Jenny L Mccardell, Jenny L Chisem
16 Jul 2009
21 CFR 211.110(a)
Written in-process control procedures
Cited by Omotunde O Osunsanmi, Christian Lynch
Investigators
FDA investigators tied to this site in the record.
Leonard H Lavi4 insp.
Prabhu P Raju2 insp.
Omotunde O Osunsanmi2 insp.
Dawn M Braswell1 insp.
James R Montero1 insp.
Jenny L Mccardell1 insp.
Jenny L Chisem1 insp.
James A Lane1 insp.
Guang Gao1 insp.
Sara J Dent Acosta1 insp.
Gene D Arcy1 insp.
Uros V Djekic1 insp.
Charles L Larson1 insp.
Ademola O Daramola1 insp.
Allen F Hall1 insp.
Christian Lynch1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hologic, Inc.'s 6 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