Overview
- 16 public-safe observations are available for this inspection.
- 6 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.
9 Oct 2015
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Erika V Butler, Pratik S Upadhyay
9 Oct 2015
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Erika V Butler, Pratik S Upadhyay
9 Oct 2015
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Erika V Butler, Pratik S Upadhyay
Inspected site
ULUMEDICA LABORATORIES PRIVATE LIMITEDVapi, 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 | 6x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 16 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