FDA Inspection
Solvias AGSolvias AG – FDA Inspection, Nov 22, 2022
Record Details
This FDA Inspection record concerns Solvias AG, with an inspection on November 22, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Solvias AG
- Inspection Date
- November 22, 2022
- Product Type
- Drugs
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ID · c03d3bcc-5de0-494e-8db4-da386a09dda9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1193131
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Solvias AG
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2023 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 9, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 27, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 7, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 4, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Solvias AG
- FDA Inspection 1219962 - 2023-09-01
- FDA Inspection 1210338 - 2023-06-09
- FDA Inspection 1036580 - 2017-10-27
- FDA Inspection 873203 - 2014-03-07
- FDA Inspection 871241 - 2014-03-04
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