FDA Inspection
Opella Healthcare International SASOpella Healthcare International SAS – FDA Inspection, Jan 10, 2025
Record Details
This FDA Inspection record concerns Opella Healthcare International SAS, with an inspection on January 10, 2025, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 10, 2025
- Product Type
- Drugs
View Company Profile
ID · b8697760-87bc-469f-8b6c-8f8d68e8c532
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1268935
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
Other FDA inspections of Opella Healthcare International SAS
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 23, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 18, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 21, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Opella Healthcare International SAS
- FDA Inspection 1123990 - 2019-10-31
- FDA Inspection 1015497 - 2017-06-23
- FDA Inspection 946883 - 2015-09-18
- FDA Inspection 853427 - 2013-09-19
- FDA Inspection 754638 - 2011-10-21
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