Starkey Global Distribution Center FDA Record
Starkey Global Distribution Center has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Starkey Global Distribution Center" is on file.
- Latest inspection
- Mar 20, 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 | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 20, 2025 | Plainfield, IN | Devices | No Action Indicated (NAI) | 3019622583 |
- 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 3019622583 | Plainfield, IN | 1 | Mar 20, 2025 |
Starkey Global Distribution Center and the FDA: common questions
Has Starkey Global Distribution Center received an FDA warning letter?
No FDA warning letter addressed to the name "Starkey Global Distribution 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 Starkey Global Distribution Center received an FDA Form 483?
FDA has not published a Form 483 for "Starkey Global Distribution Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Starkey Global Distribution Center?
The most recent FDA inspection on file ended Mar 20, 2025 at Plainfield, IN and was classified NAI. FDA has 1 inspection of Starkey Global Distribution Center on file.
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