Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
3 Dec 2010
21 CFR 111.25(a)
Procedures - calibrating instruments
Cited by Nicole E Knowlton, Joshua J Silvestri
3 Dec 2010
21 CFR 111.70(c)(2)
Specifications identity, purity strength, composition
Cited by Nicole E Knowlton, Joshua J Silvestri
3 Dec 2010
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Nicole E Knowlton, Joshua J Silvestri
3 Dec 2010
21 CFR 111.103
Written procedures - quality control operations
Cited by Nicole E Knowlton, Joshua J Silvestri
3 Dec 2010
21 CFR 111.210(h)(3)
Master manufacturing record - specific actions; quality
Cited by Nicole E Knowlton, Joshua J Silvestri
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 111.103 | 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(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 111.315(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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