FDA Inspection
Rafarm S.A.Rafarm S.A. – FDA Inspection, Oct 17, 2017
Record Details
This FDA Inspection record concerns Rafarm S.A., with an inspection on October 17, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · ebf080e1-9f3e-490d-bf48-8b531b95a96d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030183
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188(b)(13)Results of drug product inspections and examinations
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
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Other FDA inspections of Rafarm S.A.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2024 | VAI | Drug Quality Assurance | |
| May 19, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 4, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 11, 2020 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 30, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for Rafarm S.A.
- FDA Inspection 1300434 - 2024-06-21
- FDA Inspection 1225663 - 2023-05-19
- FDA Inspection 1155967 - 2021-06-04
- FDA Inspection 1123693 - 2020-03-11
- FDA Inspection 1101881 - 2019-07-30
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