Overview
- 15 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.
4 Dec 2009
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Ileana Barreto-Pettit, Dawn M Mccabe
4 Dec 2009
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Ileana Barreto-Pettit, Dawn M Mccabe
4 Dec 2009
21 CFR 211.80(a)
Written Procedures Not Followed
Cited by Ileana Barreto-Pettit, Dawn M Mccabe
4 Dec 2009
21 CFR 211.84(e)
Rejecting When Specifications Not Met
Cited by Ileana Barreto-Pettit, Dawn M Mccabe
Inspected site
ADAveva Drug Delivery Systems Inc.Miramar, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 15 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