FDA Inspection
Quinta Analytica s.r.o.Quinta Analytica s.r.o. – FDA Inspection, Feb 5, 2016
Record Details
This FDA Inspection record concerns Quinta Analytica s.r.o., with an inspection on February 5, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Quinta Analytica s.r.o.
- Inspection Date
- February 5, 2016
- Product Type
- Drugs
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ID · 174e66e8-b076-49b5-a3d3-1604cf7221b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 961301
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of Quinta Analytica s.r.o.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2025 | Not classified | Office of Inspections and Investigations | |
| November 3, 2022 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 20, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 16, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 27, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Quinta Analytica s.r.o.
- FDA Inspection 1260984 - 2025-01-10
- FDA Inspection 1191579 - 2022-11-03
- FDA Inspection 1155913 - 2021-04-20
- FDA Inspection 1093399 - 2019-01-16
- FDA Inspection 826686 - 2013-03-27
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