Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
Cleaning Compounds
Cited by Scott A Jepson, Antonetta M Colacchio, Blythe N Freihage
Raw Material Controls
Cited by Scott A Jepson, Antonetta M Colacchio, Blythe N Freihage
Hazard Analysis
Cited by Scott A Jepson, Antonetta M Colacchio, Blythe N Freihage
Preventive Controls
Cited by Scott A Jepson, Antonetta M Colacchio, Blythe N Freihage
Product Testing
Cited by Scott A Jepson, Antonetta M Colacchio, Blythe N Freihage
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 507.19(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.25(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.33(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.34(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.49(a)(2) | 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