Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
15 Jan 2025
21 CFR 211.110(d)
Rejected in-process materials not quarantined
Cited by Pushpa S Jayasekara
15 Jan 2025
21 CFR 211.186(a)
Signature and checking of records -- 2 persons
Cited by Pushpa S Jayasekara
15 Jan 2025
21 CFR 211.188(b)(11)
Identification of Persons Performing Significant Steps
Cited by Pushpa S Jayasekara
15 Jan 2025
FDCA 582(b)(4)
Systems in place to comply with verifciation requirements
Cited by Pushpa S Jayasekara
Inspected site
JCJubilant Cadista Pharmaceuticals, Inc.Salisbury, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | 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 5 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