McNeil Healthcare Packaging, LLC FDA Record
McNeil Healthcare Packaging, LLC has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "McNeil Healthcare Packaging, LLC" is on file.
- Latest inspection
- Oct 28, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 4 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 28, 2025 | Fairfield, NJ | Devices | No Action Indicated (NAI) | 1000305719 |
| Oct 24, 2019 | Fairfield, NJ | Devices | No Action Indicated (NAI) | 1000305719 |
| Aug 13, 2015 | Fairfield, NJ | Devices | Voluntary Action Indicated (VAI) | 1000305719 |
| Jun 24, 2014 | Fairfield, NJ | Devices | No Action Indicated (NAI) | 1000305719 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1000305719 | Fairfield, NJ | 4 | Oct 28, 2025 |
McNeil Healthcare Packaging, LLC and the FDA: common questions
Has McNeil Healthcare Packaging, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "McNeil Healthcare Packaging, LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has McNeil Healthcare Packaging, LLC received an FDA Form 483?
FDA has not published a Form 483 for "McNeil Healthcare Packaging, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect McNeil Healthcare Packaging, LLC?
The most recent FDA inspection on file ended Oct 28, 2025 at Fairfield, NJ and was classified NAI. FDA has 4 inspections of McNeil Healthcare Packaging, LLC on file.
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