Warning letter
The Royal Ice Cream Company Inc.: warning letter of Jul 28, 2022
FDA warning letter 630433 · Office of Human and Animal Food Operations East – Division 1
Key facts
| Reference number | 630433 |
|---|---|
| Company | The Royal Ice Cream Company Inc. |
| Subject | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
| Issue date | Jul 28, 2022 |
| Posted date | Sep 13, 2022 |
| Issuing office | Office of Human and Animal Food Operations East – Division 1 |
| Product type | Food/Cosmetics |
| CFR sections cited | 117.430(b)(1)(ii), 117.430(b), 117, 117.80, 117.35(a), 117.40(a)(1), 117.135(a)(1), 117.135(c)(3), 117.135(c)(3)(ii), 117.165(b)(3)(iii), 117.410(c), 117.165(b)(3) |
| Inspection city | Manchester |
| Inspection ZIP | 06040 |
| Inspection start date | Jan 19, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: