Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
8 Jun 2015
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Ashley A Mutawakkil, Kelly A Lynch, Bridgette M Mattern
8 Jun 2015
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Ashley A Mutawakkil, Kelly A Lynch, Bridgette M Mattern
8 Jun 2015
21 CFR 211.22(a)
Contract drug products--lack of responsibility
Cited by Ashley A Mutawakkil, Kelly A Lynch, Bridgette M Mattern
Inspected site
SVStrategic Veterinary Pharmaceuticals, Inc.Elwood, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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