Overview
- 64 public-safe observations are available for this inspection.
- 16 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.
29 Jul 2016
21 CFR 1010.2(a)
Lack of certification of conformance
Cited by Joshua J Silvestri, Benjamin K Wolf
29 Jul 2016
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Joshua J Silvestri, Benjamin K Wolf
Inspected site
DIDenterprise International, Inc.Ormond Beach, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1010.2(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1010.3(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 4x |
Full 483 report
Get the verbatim text of all 64 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