Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
Potable water - representative samples frequency
Cited by Elizabeth P Mayer, Karen M Labounty, Raquel L Coleman, Kelsey L Vansickle, Jennifer A Downie
Thermal process - frequency, monitor temperature
Cited by Elizabeth P Mayer, Karen M Labounty, Raquel L Coleman, Kelsey L Vansickle, Jennifer A Downie
Clean, sanitize, maintain equipment & utensils
Cited by Elizabeth P Mayer, Karen M Labounty, Raquel L Coleman, Kelsey L Vansickle, Jennifer A Downie
System of process controls to prevent adulteration
Cited by Elizabeth P Mayer, Karen M Labounty, Raquel L Coleman, Kelsey L Vansickle, Jennifer A Downie
Production aggregate sample - final stage, distribution
Cited by Elizabeth P Mayer, Karen M Labounty, Raquel L Coleman, Kelsey L Vansickle, Jennifer A Downie
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 106.20(f)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(e)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.55(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.55(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.91(a)(4) | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 observations
The source PDF, 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