Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 7 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Record - date, time
Cited by Elizabeth P Mayer, Bing Lin, Melissa M Schafer, Jennifer R Johnson, Misty D Harvey, Tessy O Martins, Elra C Fox
Personnel - hand washing
Cited by Elizabeth P Mayer, Bing Lin, Melissa M Schafer, Jennifer R Johnson, Misty D Harvey, Tessy O Martins, Elra C Fox
Clean, sanitize, maintain equipment & utensils
Cited by Elizabeth P Mayer, Bing Lin, Melissa M Schafer, Jennifer R Johnson, Misty D Harvey, Tessy O Martins, Elra C Fox
System of production; in-process controls
Cited by Elizabeth P Mayer, Bing Lin, Melissa M Schafer, Jennifer R Johnson, Misty D Harvey, Tessy O Martins, Elra C Fox
Operating conditions - observed, recorded
Cited by Elizabeth P Mayer, Bing Lin, Melissa M Schafer, Jennifer R Johnson, Misty D Harvey, Tessy O Martins, Elra C Fox
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 106.10(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.100(f)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.6(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(g)(2)(ii)(C) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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