Overview
- 7 public-safe observations are available for this inspection.
- 6 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.
1 May 2017
21 CFR 110.80(b)(2)
Manufacturing conditions
Cited by Jamie R Thompson, Alecia L Marson, Jennifer Guttuso
1 May 2017
21 CFR 123.7(a)
Corrective action per predetermined plan
Cited by Jamie R Thompson, Alecia L Marson, Jennifer Guttuso
1 May 2017
21 CFR 123.11(b)
Sanitation monitoring
Cited by Jamie R Thompson, Alecia L Marson, Jennifer Guttuso
1 May 2017
21 CFR 123.6(a)
Hazard analysis
Cited by Jamie R Thompson, Alecia L Marson, Jennifer Guttuso
Inspected site
RWRushing Waters Fisheries, LLCPalmyra, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.7(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(2) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 7 observations
The source PDF and every observation in full, 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