Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-09-23.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Sep 2016 – 23 Sep 2016 | Foods & Cosmetics | 483 | On file |
| 11 Jul 2013 – 19 Jul 2013 | Foods & Cosmetics | 483 | View 483 → |
| 3 May 2012 | Not recorded | 483 | View 483 → |
| 3 Dec 2010 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Jul 2013
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Melanie W Pishnery, Mizanne E Lewis
19 Jul 2013
21 CFR 111.205(b)(1)
Master manufacturing record - specifications; quality
Cited by Melanie W Pishnery, Mizanne E Lewis
19 Jul 2013
21 CFR 111.210(h)(2)
Master manufacturing record - sampling, tests, examinations
Cited by Melanie W Pishnery, Mizanne E Lewis
3 May 2012
21 CFR 111.25
Equipment - procedures
Cited by Nicole E Knowlton, Jennifer A Robinson, Melanie G Warzala
3 May 2012
21 CFR 111.30(b)
Equipment - automated - suitability
Cited by Nicole E Knowlton, Jennifer A Robinson, Melanie G Warzala
Investigators
FDA investigators tied to this site in the record.
Nicole E Knowlton2 insp.
David P King1 insp.
Melanie W Pishnery1 insp.
Mizanne E Lewis1 insp.
Jennifer A Robinson1 insp.
Melanie G Warzala1 insp.
Joshua J Silvestri1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | 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(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.403 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.77(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Dynamic Pharmaceuticals, Inc.'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