FDA Inspection
GE Healthcare Inc.GE Healthcare Inc. – FDA Inspection, Apr 8, 2010
Record Details
This FDA Inspection record concerns GE Healthcare Inc., with an inspection on April 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GE Healthcare Inc.
- Inspection Date
- April 8, 2010
- Product Type
- Devices
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ID · ca2e14f3-f0ed-4029-ae03-1fec3cb6814d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 657027
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of GE Healthcare Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2024 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 2, 2023 | Not classified | Chicago District Office | |
| January 24, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 6, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GE Healthcare Inc.
- FDA Inspection 1287530 - 2025-09-19
- FDA Inspection 1232232 - 2024-03-08
- FDA Inspection 1221712 - 2023-10-02
- FDA Inspection 1117219 - 2020-01-24
- FDA Inspection 1026911 - 2017-09-06
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