Overview
- 13 public-safe observations are available for this inspection.
- 13 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
9 Sep 2010
21 CFR 111.8
Written procedures - personnel qualifications
Cited by Meredith P Soehl, Stephanie Durso
9 Sep 2010
21 CFR 111.25(a)
Procedures - calibrating instruments
Cited by Meredith P Soehl, Stephanie Durso
9 Sep 2010
21 CFR 111.25(c)
Procedures - equipment - cleaning, sanitizing
Cited by Meredith P Soehl, Stephanie Durso
9 Sep 2010
21 CFR 111.35(b)(3)
Documentation - instruments, controls; calibrations
Cited by Meredith P Soehl, Stephanie Durso
9 Sep 2010
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Meredith P Soehl, Stephanie Durso
Inspected site
DPDanbury Pharma, LLCFarmingdale, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 111.25(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 111.303 | 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 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.8 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 13 observations
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