Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
6 Jul 2012
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Liatte Krueger, Melba T Rivera Clavell
6 Jul 2012
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Liatte Krueger, Melba T Rivera Clavell
6 Jul 2012
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Liatte Krueger, Melba T Rivera Clavell
6 Jul 2012
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Liatte Krueger, Melba T Rivera Clavell
Inspected site
DPDAVA Pharmaceuticals, Inc.Fort Lee, United States
Inspection team
LKLiatte Krueger
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 observations
The source PDF and 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