FDA Inspection
GE Healthcare Ireland LimitedGE Healthcare Ireland Limited – FDA Inspection, Sep 15, 2014
Record Details
This FDA Inspection record concerns GE Healthcare Ireland Limited, with an inspection on September 15, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 15, 2014
- Product Type
- Drugs
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ID · 842f7e37-3c2c-4df6-9776-86581100335e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 898343
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.56(b)Written sanitation procedures not followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of GE Healthcare Ireland Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 16, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 28, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for GE Healthcare Ireland Limited
- FDA Inspection 1200558 - 2021-11-05
- FDA Inspection 1061983 - 2018-07-16
- FDA Inspection 990089 - 2016-06-28
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