Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
11 Apr 2014
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Jessica L Pressley, Ileana Barreto-Pettit
11 Apr 2014
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jessica L Pressley, Ileana Barreto-Pettit
11 Apr 2014
21 CFR 211.68(b)
Computer control of master formula records
Cited by Jessica L Pressley, Ileana Barreto-Pettit
11 Apr 2014
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Jessica L Pressley, Ileana Barreto-Pettit
11 Apr 2014
21 CFR 211.130
Procedures are written, and followed
Cited by Jessica L Pressley, Ileana Barreto-Pettit
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 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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