Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-07-28.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jul 2017 – 28 Jul 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Apr 2017 | Medical Devices & Rad Health | Clean | |
| 22 Apr 2014 – 25 Apr 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Jun 2012 | Not recorded | Clean | |
| 15 Dec 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Jul 2017
21 CFR 1003.10(a)
FDA not notified of defect or noncompliance
Cited by Eric C Schmitt, Yuan Fang
28 Jul 2017
21 CFR 1020.30(g)
Providing adequate assembly information
Cited by Eric C Schmitt, Yuan Fang
Investigators
FDA investigators tied to this site in the record.
Eric C Schmitt1 insp.
Yuan Fang1 insp.
Michael G Mayfield1 insp.
Jeffrey J Thibodeau1 insp.
John A Sciacchitano1 insp.
Edward J Janik1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1002.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1002.30(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1002.30(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1003.10(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1020.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hologic, Inc.'s 3 Form 483s
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