FDA Inspection
Inversiones & Negocios, S.A. (Inesa)Inversiones & Negocios, S.A. (Inesa) – FDA Inspection, May 4, 2012
Record Details
This FDA Inspection record concerns Inversiones & Negocios, S.A. (Inesa), with an inspection on May 4, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 4, 2012
- Product Type
- Drugs
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ID · 453e340d-bddd-4b11-b293-3126cbef04e6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 782835
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(1)Sampling and testing procedures described
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Other FDA inspections of Inversiones & Negocios, S.A. (Inesa)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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