Overview
- 13 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
22 Jan 2026
21 CFR 211.110(a)
Written in-process control procedures
Cited by Justin A Boyd, Khoa Nathan V Tran, Karen A Briggs
22 Jan 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Justin A Boyd, Khoa Nathan V Tran, Karen A Briggs
22 Jan 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Justin A Boyd, Khoa Nathan V Tran, Karen A Briggs
22 Jan 2026
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Justin A Boyd, Khoa Nathan V Tran, Karen A Briggs
22 Jan 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Justin A Boyd, Khoa Nathan V Tran, Karen A Briggs
Inspected site
EVExcel VisionAnnonay, France
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Source document
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PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 13 observations
The source PDF, 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