Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
1 Mar 2018
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Jai P Singh, Valerie L Whipp
1 Mar 2018
21 CFR 211.25(b)
Supervisor Training/Education/Experience
Cited by Jai P Singh, Valerie L Whipp
1 Mar 2018
21 CFR 211.52
Washing and toilet facilities are deficient
Cited by Jai P Singh, Valerie L Whipp
Inspected site
SPSimpex Pharma Pvt. LtdSigaddi, Kotdwar, India
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.16 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | 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