Overview
- 5 public-safe observations are available for this inspection.
- 4 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.
28 Jun 2012
21 CFR 211.110(a)
Written in-process control procedures
Cited by Libia M Lugo, Stephen D Brown
28 Jun 2012
21 CFR 211.186(b)(7)
Theoretical yield statement including percentages
Cited by Libia M Lugo, Stephen D Brown
28 Jun 2012
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Libia M Lugo, Stephen D Brown
Inspected site
SLSenador Laboratories Private LimitedAhmedabad, India
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
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