Overview
- 8 public-safe observations are available for this inspection.
- 7 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.
18 Dec 2020
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Brenna L Macdowell, Frank J Koch, Alysia M Salonia
18 Dec 2020
21 CFR 117.135(c)(2)
Allergen Controls Procedures
Cited by Brenna L Macdowell, Frank J Koch, Alysia M Salonia
18 Dec 2020
21 CFR 117.135(c)(3)
Sanitation Controls Procedures
Cited by Brenna L Macdowell, Frank J Koch, Alysia M Salonia
18 Dec 2020
21 CFR 117.150(a)(2)
Allergen Controls Corrective Action Procedures - Content
Cited by Brenna L Macdowell, Frank J Koch, Alysia M Salonia
18 Dec 2020
21 CFR 117.165(b)
Process Controls Verif Procedures: Establish Implement
Cited by Brenna L Macdowell, Frank J Koch, Alysia M Salonia
Inspected site
TRThe Royal Ice Cream Company Inc.Manchester, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.165(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.150(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.305 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.415(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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