Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Minimize potential contamination - appropriate measures
Cited by Elizabeth P Mayer, Craig P Seaborn, Bailey A Uetrecht, Melissa M Schafer, Alec M O'Neal
Equipment, utensil - installed to function, clean, maintain
Cited by Elizabeth P Mayer, Craig P Seaborn, Bailey A Uetrecht, Melissa M Schafer, Alec M O'Neal
Controls - nutrient levels, contamination
Cited by Elizabeth P Mayer, Craig P Seaborn, Bailey A Uetrecht, Melissa M Schafer, Alec M O'Neal
System of process controls to prevent adulteration
Cited by Elizabeth P Mayer, Craig P Seaborn, Bailey A Uetrecht, Melissa M Schafer, Alec M O'Neal
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 106.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.50(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.55(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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