Penn State Health Holy Spirit Medical Center FDA Record
- Latest inspection NAI · Apr 24, 2025
- No warning letters matched by name
Penn State Health Holy Spirit Medical Center has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Penn State Health Holy Spirit Medical Center" is on file.
- Latest inspection
- Apr 24, 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 | 7 | 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 Holy Spirit 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 | 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 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 24, 2025 | Camp Hill, PA | Biologics | No Action Indicated (NAI) | 2571089 |
| Apr 18, 2019 | Camp Hill, PA | Biologics | No Action Indicated (NAI) | 2571089 |
| Jul 19, 2017 | Camp Hill, PA | Biologics | No Action Indicated (NAI) | 2571089 |
| Jul 8, 2015 | Camp Hill, PA | Biologics | No Action Indicated (NAI) | 2571089 |
| Sep 5, 2013 | Camp Hill, PA | Biologics | No Action Indicated (NAI) | 2571089 |
| Sep 29, 2011 | Camp Hill, PA | Biologics | No Action Indicated (NAI) | 2571089 |
| Oct 22, 2009 | Camp Hill, PA | Biologics | No Action Indicated (NAI) | 2571089 |
- 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 2571089 | Camp Hill, PA | 7 | Apr 24, 2025 |
Penn State Health Holy Spirit Medical Center and the FDA: common questions
Has Penn State Health Holy Spirit Medical Center received an FDA warning letter?
No FDA warning letter addressed to the name "Penn State Health Holy Spirit 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 Holy Spirit Medical Center received an FDA Form 483?
FDA has not published a Form 483 for "Penn State Health Holy Spirit Medical Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Penn State Health Holy Spirit Medical Center?
The most recent FDA inspection on file ended Apr 24, 2025 at Camp Hill, PA and was classified NAI. FDA has 7 inspections of Penn State Health Holy Spirit Medical Center on file.
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