Amco International Manufacturing & Design, Inc. FDA Record
Amco International Manufacturing & Design, Inc. has 0 FDA recalls, 7 inspections, 5 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Amco International Manufacturing & Design, Inc., the most recent on Jun 25, 2024.
- Latest inspection
- Mar 20, 2024 · OAI
- Latest 510(k)
- Aug 7, 2009
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 5 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 7 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 1 | 1 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Amco International Manufacturing & Design, Inc. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jun 25, 2024 · Letter on fda.gov | Unapproved Device Violation | Center for Devices and Radiological Health |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 20, 2024 | Brooklyn, NY | Devices | Official Action Indicated (OAI) | 3005906887 |
| May 27, 2021 | Brooklyn, NY | Devices | Voluntary Action Indicated (VAI) | 3005906887 |
| Jun 26, 2018 | Brooklyn, NY | Devices | No Action Indicated (NAI) | 3005906887 |
| Jun 30, 2015 | Brooklyn, NY | Devices | Voluntary Action Indicated (VAI) | 3005906887 |
| Nov 21, 2013 | Brooklyn, NY | Devices | Voluntary Action Indicated (VAI) | 3005906887 |
| Mar 28, 2012 | Brooklyn, NY | Devices | No Action Indicated (NAI) | 3005906887 |
| Mar 17, 2010 | Brooklyn, NY | Devices | Voluntary Action Indicated (VAI) | 3005906887 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Amco International Manufacturing & Design, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3005906887 | Brooklyn, NY | 7 | Mar 20, 2024 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K091548 | AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A | Aug 7, 2009 |
| K082861 | AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE… | Nov 25, 2008 |
| K073716 | LIFE+CEL OR LIFECEL BATTERY | Apr 11, 2008 |
| K072596 | LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 | Jan 24, 2008 |
| K071164 | LIFE+CEL BATTERY | Dec 7, 2007 |
Amco International Manufacturing & Design, Inc. and the FDA: common questions
Has Amco International Manufacturing & Design, Inc. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Amco International Manufacturing & Design, Inc.. The most recent is dated Jun 25, 2024, with the subject "Unapproved Device Violation".
Has Amco International Manufacturing & Design, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Amco International Manufacturing & Design, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Amco International Manufacturing & Design, Inc.?
The most recent FDA inspection on file ended Mar 20, 2024 at Brooklyn, NY and was classified OAI. FDA has 7 inspections of Amco International Manufacturing & Design, Inc. on file, 1 of them classified OAI (official action indicated).
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