FDA Inspection
Farmaqro, S.A. de C.V.Farmaqro, S.A. de C.V. – FDA Inspection, Jul 29, 2016
Record Details
This FDA Inspection record concerns Farmaqro, S.A. de C.V., with an inspection on July 29, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Farmaqro, S.A. de C.V.
- Inspection Date
- July 29, 2016
- Product Type
- Drugs
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ID · c5d89adc-1e02-4839-9ddf-65083c2054d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995560
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Farmaqro, S.A. de C.V.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Farmaqro, S.A. de C.V.
- FDA Inspection 1053250 - 2018-05-25
- FDA Inspection 882295 - 2014-05-16
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