Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
29 Jun 2012
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Freddy Ortiz Colon, Virgilio F Pacio
29 Jun 2012
21 CFR 211.63
Equipment Design, Size and Location
Cited by Freddy Ortiz Colon, Virgilio F Pacio
29 Jun 2012
21 CFR 211.68(b)
Computer control of master formula records
Cited by Freddy Ortiz Colon, Virgilio F Pacio
29 Jun 2012
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by Freddy Ortiz Colon, Virgilio F Pacio
29 Jun 2012
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Freddy Ortiz Colon, Virgilio F Pacio
Inspected site
SHSoftgel Healthcare Private LimitedPudupakkam, Kancheepuram, 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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