Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-11-06.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Oct 2014 – 6 Nov 2014 | Foods & Cosmetics | 483 | View 483 → |
| 24 Oct 2013 – 1 Nov 2013 | Foods & Cosmetics | 483 | View 483 → |
| 29 Mar 2012 | Not recorded | 483 | View 483 → |
| 9 Sep 2010 | Not recorded | 483 | View 483 → |
| 2 Jul 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Nov 2014
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Meredith P Soehl
1 Nov 2013
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Meredith P Soehl
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(c)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.430(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.8 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.87 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Danbury Pharma, LLC's 4 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