Overview
- 224 public-safe observations are available for this inspection.
- 46 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.
22 Apr 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jose E Melendez, Parul M Patel
22 Apr 2016
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jose E Melendez, Parul M Patel
22 Apr 2016
21 CFR 211.84(d)(2)
Testing Each Component for Conformity with Specs
Cited by Jose E Melendez, Parul M Patel
22 Apr 2016
21 CFR 211.115(a)
Reprocessing procedures lack steps to be taken
Cited by Jose E Melendez, Parul M Patel
22 Apr 2016
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Jose E Melendez, Parul M Patel
Inspected site
STSomerset Therapeutics Private LimitedBengaluru, India
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.208 | Cited across public-safe Form 483 observations | 15x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 15x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.48(a) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.115(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.184(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.65(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b)(5) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(c)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(c)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.94(d) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 224 observations
The full inspection record, as Atlas holds it, 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