Warning letter
Elwood International, Inc.: warning letter of Sep 27, 2018
FDA warning letter 552203 · New York District Office
Key facts
| Reference number | 552203 |
|---|---|
| Company | Elwood International, Inc. |
| Subject | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
| Issue date | Sep 27, 2018 |
| Posted date | Oct 16, 2018 |
| Issuing office | New York District Office |
| Product type | Food/Cosmetics |
| CFR sections cited | 108, 113, 117, 117.5, 117.40, 113.3(n), 114.3(b), 117.20(b)(4), 117.35(a), 117.35(c), 117.37(f), 117.80(a)(1) and 2 more |
| Inspection city | Copiague |
| Inspection ZIP | 11726 |
| Inspection start date | Jan 8, 2018 |
| 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: