Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-01-05.
At a glance
Inspections
5
Form 483s
1
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jan 2024 – 5 Jan 2024 | Human Drugs | Clean | |
| 23 Jan 2019 – 29 Jan 2019 | Human Drugs | Clean | |
| 14 Feb 2017 – 21 Feb 2017 | Human Drugs | 483 | View 483 → |
| 22 Sep 2014 – 25 Sep 2014 | Human Drugs | Clean | |
| 17 May 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Feb 2017
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Dien N Nguyen, Christopher Janik
21 Feb 2017
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Dien N Nguyen, Christopher Janik
Investigators
FDA investigators tied to this site in the record.
Jose A Torres1 insp.
Michael P Anthony1 insp.
Dien N Nguyen1 insp.
Christopher Janik1 insp.
Jonathan G Matrisciano1 insp.
Nealie C Newberger1 insp.
Nealie Newberger1 insp.
M. P Murphy1 insp.
Diane C Thibodeau1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Breckenridge Pharmaceutical, Inc's 1 Form 483
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