Overview
- 11 public-safe observations are available for this inspection.
- 11 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
3 May 2012
21 CFR 111.30(e)
Equipment - controls, intended use
Cited by Nicole E Knowlton, Jennifer A Robinson, Melanie G Warzala
3 May 2012
21 CFR 111.77(b)
Specifications not met - identity; component, reject
Cited by Nicole E Knowlton, Jennifer A Robinson, Melanie G Warzala
3 May 2012
21 CFR 111.113(a)(1)
QC production, process control; material review, disposition
Cited by Nicole E Knowlton, Jennifer A Robinson, Melanie G Warzala
Inspected site
DPDynamic Pharmaceuticals, Inc.Brooksville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25 | 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 111.403 | 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 |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 11 observations
The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere