Warning letter
AMCO International Manufacturing & Design, Inc.: warning letter of Jun 25, 2024
FDA warning letter 681557 · Center for Devices and Radiological Health
Key facts
| Reference number | 681557 |
|---|---|
| Company | AMCO International Manufacturing & Design, Inc. |
| Subject | Unapproved Device Violation |
| Issue date | Jun 25, 2024 |
| Posted date | Jul 30, 2024 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 870.5310 |
| Inspection city | Brooklyn |
| Inspection ZIP | 11211 |
| Inspection start date | Mar 11, 2024 |
| 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: