FDA Inspection
FarmeaFarmea – FDA Inspection, Jun 12, 2015
Record Details
This FDA Inspection record concerns Farmea, with an inspection on June 12, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Farmea
- Inspection Date
- June 12, 2015
- Product Type
- Drugs
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ID · c90c89ba-5c1c-4435-80b6-7858ce740466
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 942862
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.111Establishment of time limitations
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Other FDA inspections of Farmea
8| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 21, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 2, 2017 | Not classified | Office of Inspections and Investigations | |
| April 1, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 14, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Farmea
- FDA Inspection 1239201 - 2022-12-01
- FDA Inspection 1117823 - 2019-02-21
- FDA Inspection 1025627 - 2017-06-02
- FDA Inspection 969058 - 2016-04-01
- FDA Inspection 868797 - 2014-02-14
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