Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
7 Aug 2015
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Michael L Casner, Eric L Dong, Deborah J Parris
7 Aug 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Michael L Casner, Eric L Dong, Deborah J Parris
7 Aug 2015
21 CFR 211.194(a)
Complete test data included in records
Cited by Michael L Casner, Eric L Dong, Deborah J Parris
7 Aug 2015
21 CFR 211.204
Returned drug procedures in writing and followed
Cited by Michael L Casner, Eric L Dong, Deborah J Parris
7 Aug 2015
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Michael L Casner, Eric L Dong, Deborah J Parris
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 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(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 7 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