Overview
- 12 public-safe observations are available for this inspection.
- 12 structured CFR citations are represented.
- 6 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Grounds
Cited by Jocelyn C Turner, Margaret M Annes, Michael L Jones, Lauren R Brady, Preston B Hoover, Lauren R Howell
Sanitary operations - Plant maintenance
Cited by Jocelyn C Turner, Margaret M Annes, Michael L Jones, Lauren R Brady, Preston B Hoover, Lauren R Howell
Pest control
Cited by Jocelyn C Turner, Margaret M Annes, Michael L Jones, Lauren R Brady, Preston B Hoover, Lauren R Howell
Storage under appropriate conditions
Cited by Jocelyn C Turner, Margaret M Annes, Michael L Jones, Lauren R Brady, Preston B Hoover, Lauren R Howell
Distribution Record Requirements
Cited by Jocelyn C Turner, Margaret M Annes, Michael L Jones, Lauren R Brady, Preston B Hoover, Lauren R Howell
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.196 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.19(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.27(a) | 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 12 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