FDA Inspection
Gelpharma S.A. de C.V.Gelpharma S.A. de C.V. – FDA Inspection, Dec 9, 2016
Record Details
This FDA Inspection record concerns Gelpharma S.A. de C.V., with an inspection on December 9, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 00b0097e-d937-4fd5-bf00-9f8a9f7f3d04
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005806
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.194(a)(5)Testing Calculations
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Gelpharma S.A. de C.V.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 8, 2014 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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