Warning letter
Gate Gourmet Inc.: warning letter of Mar 29, 2018
FDA warning letter 543440 · Cincinnati District Office
Key facts
| Reference number | 543440 |
|---|---|
| Company | Gate Gourmet Inc. |
| Subject | CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated  |
| Issue date | Mar 29, 2018 |
| Posted date | Apr 10, 2018 |
| Issuing office | Cincinnati District Office |
| Product type | Food/Cosmetics |
| CFR sections cited | 117.35(c), 117, 117.35(d), 117.37(b)(3), 117.80(c)(1), 117.80(c)(2), 1250 |
| Inspection city | Erlanger |
| Inspection ZIP | 41018 |
| Inspection start date | Nov 29, 2017 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 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: