Overview
- 3 public-safe observations are available for this inspection.
- 3 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 Mar 2018
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Anastasia M Shields, Carrie A Hughes
6 Mar 2018
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Anastasia M Shields, Carrie A Hughes
6 Mar 2018
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Anastasia M Shields, Carrie A Hughes
Inspected site
EPEUGIA Pharma Specialities LimitedRiico Industrial Area, India
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | 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 3 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