Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
18 Mar 2014
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Debra M Emerson, Jeremy W Rotton
18 Mar 2014
21 CFR 211.67(b)
Written procedures fail to include
Cited by Debra M Emerson, Jeremy W Rotton
18 Mar 2014
21 CFR 211.84(d)(6)
Microbiological Contamination Exam
Cited by Debra M Emerson, Jeremy W Rotton
18 Mar 2014
21 CFR 211.110(a)
Control procedures fail to include the following
Cited by Debra M Emerson, Jeremy W Rotton
18 Mar 2014
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Debra M Emerson, Jeremy W Rotton
Inspected site
FAFareva AmboisePoce Sur Cisse, France
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | 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 9 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