FDA Inspection
CU Chemie Uetikon GmbHCU Chemie Uetikon GmbH – FDA Inspection, Apr 20, 2018
Record Details
This FDA Inspection record concerns CU Chemie Uetikon GmbH, with an inspection on April 20, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Yumi J. Hiramine (Issuing Officer)
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ID · 7b0d668a-f9b6-4add-96b8-e84948cf3daf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054154
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of CU Chemie Uetikon GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 21, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 1, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for CU Chemie Uetikon GmbH
- FDA Inspection 1203201 - 2021-11-12
- FDA Inspection 969729 - 2016-04-21
- FDA Inspection 854576 - 2013-05-16
- FDA Inspection 655446 - 2010-04-01
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