FDA Inspection
GE Healthcare ASGE Healthcare AS – FDA Inspection, Aug 27, 2019
Record Details
This FDA Inspection record concerns GE Healthcare AS, with an inspection on August 27, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c5b9616f-396b-4f7e-9d13-e2bb5eef80af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100537
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 212.50(a)Written control procedures
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Other FDA inspections of GE Healthcare AS
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 12, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 3, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for GE Healthcare AS
- FDA Inspection 1236691 - 2024-04-23
- FDA Inspection 1037481 - 2017-11-10
- FDA Inspection 959608 - 2016-02-12
- FDA Inspection 915526 - 2015-02-03
- FDA Inspection 810910 - 2012-12-13
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