FDA Inspection
Opella Healthcare International SASOpella Healthcare International SAS – FDA Inspection, Sep 18, 2015
Record Details
This FDA Inspection record concerns Opella Healthcare International SAS, with an inspection on September 18, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 18, 2015
- Product Type
- Drugs
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ID · e8f8ad70-e8e2-4f7d-b190-d3a9600b2da0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 946883
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Opella Healthcare International SAS
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2025 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 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 1268935 - 2025-01-10
- FDA Inspection 1123990 - 2019-10-31
- FDA Inspection 1015497 - 2017-06-23
- FDA Inspection 853427 - 2013-09-19
- FDA Inspection 754638 - 2011-10-21
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