Overview
- 7 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-27.
At a glance
Inspections
7
Form 483s
7
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Nov 2024 – 27 Nov 2024 | Human Drugs | 483 | View 483 → |
| 25 May 2017 – 5 Jun 2017 | Human Drugs | 483 | View 483 → |
| 6 May 2014 – 30 May 2014 | Human Drugs | 483 | View 483 → |
| 21 May 2013 – 13 Jun 2013 | Human Drugs | 483 | View 483 → |
| 27 Jul 2012 | Not recorded | 483 | View 483 → |
| 8 Mar 2012 | Not recorded | 483 | View 483 → |
| 11 Jul 2011 | Not recorded | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Nicholas A Violand4 insp.
Erin D Mccaffery2 insp.
Tyanna N Hadley1 insp.
Anastasia I Offordile1 insp.
Amy M Cramer1 insp.
Michael Serrano1 insp.
Jonee J Mearns1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 312.56(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.57(a) | 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 BRACCO DIAGNOSTICS INC's 7 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