FDA Inspection
Industria Farmaceutica Andromaco S.A. de C.V.Industria Farmaceutica Andromaco S.A. de C.V. – FDA Inspection, Feb 1, 2019
Record Details
This FDA Inspection record concerns Industria Farmaceutica Andromaco S.A. de C.V., with an inspection on February 1, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 1, 2019
- Product Type
- Drugs
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ID · ed5c440e-1c50-47b6-b6c7-a6efc3f51a4f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078693
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.42(c)(3)Released Material Area
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Other FDA inspections of Industria Farmaceutica Andromaco S.A. de C.V.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 1, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Industria Farmaceutica Andromaco S.A. de C.V.
- FDA Inspection 1042708 - 2018-02-01
- FDA Inspection 953016 - 2015-10-30
- FDA Inspection 786248 - 2012-06-01
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