Warning letter
Big Olaf Creamery LLC dba Big Olaf: warning letter of Dec 9, 2022
FDA warning letter 642758 · Division of Human and Animal Food Operations East IV
Key facts
| Reference number | 642758 |
|---|---|
| Company | Big Olaf Creamery LLC dba Big Olaf |
| Subject | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
| Issue date | Dec 9, 2022 |
| Posted date | Dec 27, 2022 |
| Issuing office | Division of Human and Animal Food Operations East IV |
| Product type | Food/Cosmetics |
| CFR sections cited | 117.140, 117.160, 117.410, 117, 117.126(a)(1), 117.126(a)(2), 117.130(a), 117.130(a)(2), 117.135(a)(1), 117.135(b), 117.135(c)(2), 117.135(c)(3) and 11 more |
| Inspection city | Sarasota |
| Inspection ZIP | 34232 |
| Inspection start date | Jul 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: