Penn State Health Milton S. Hershey Medical Center FDA Record
- Latest inspection NAI · Aug 13, 2025
- No warning letters matched by name
Penn State Health Milton S. Hershey Medical Center has 0 FDA recalls, 14 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Penn State Health Milton S. Hershey Medical Center" is on file.
- Latest inspection
- Aug 13, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 14 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Penn State Health Milton S. Hershey Medical Center: FDA inspections per 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 | 2 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 2 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 13, 2025 | Hershey, PA | Biologics | No Action Indicated (NAI) | 2572394 |
| Jul 20, 2023 | Hershey, PA | Biologics | No Action Indicated (NAI) | 2572394 |
| Feb 24, 2023 | Hershey, PA | Biologics | No Action Indicated (NAI) | 3003940926 |
| Mar 14, 2019 | Hershey, PA | Devices | No Action Indicated (NAI) | 3003940926 |
| Jan 22, 2019 | Hershey, PA | Biologics | No Action Indicated (NAI) | 2572394 |
| Jul 26, 2018 | Hershey, PA | Biologics | No Action Indicated (NAI) | 3003940926 |
| Dec 8, 2016 | Hershey, PA | Biologics | No Action Indicated (NAI) | 2572394 |
| Dec 12, 2014 | Hershey, PA | Biologics | No Action Indicated (NAI) | 2572394 |
| Jan 14, 2014 | Hershey, PA | Biologics | No Action Indicated (NAI) | 3003940926 |
| Mar 21, 2013 | Hershey, PA | Biologics | No Action Indicated (NAI) | 2572394 |
| Mar 30, 2011 | Hershey, PA | Biologics | No Action Indicated (NAI) | 3003940926 |
| Feb 17, 2011 | Hershey, PA | Biologics | No Action Indicated (NAI) | 2572394 |
| Aug 26, 2010 | Hershey, PA | Biologics | No Action Indicated (NAI) | 3003940926 |
| Feb 19, 2009 | Hershey, PA | Biologics | No Action Indicated (NAI) | 2572394 |
- 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 2572394 | Hershey, PA | 8 | Aug 13, 2025 |
| FEI 3003940926 | Hershey, PA | 6 | Feb 24, 2023 |
Penn State Health Milton S. Hershey Medical Center and the FDA: common questions
Has Penn State Health Milton S. Hershey Medical Center received an FDA warning letter?
No FDA warning letter addressed to the name "Penn State Health Milton S. Hershey Medical Center" 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 Penn State Health Milton S. Hershey Medical Center received an FDA Form 483?
FDA has not published a Form 483 for "Penn State Health Milton S. Hershey Medical Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Penn State Health Milton S. Hershey Medical Center?
The most recent FDA inspection on file ended Aug 13, 2025 at Hershey, PA and was classified NAI. FDA has 14 inspections of Penn State Health Milton S. Hershey Medical Center on file.
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