FDA Inspection
Industria Farmaceutica Andromaco S.A. de C.V.Industria Farmaceutica Andromaco S.A. de C.V. – FDA Inspection, Oct 30, 2015
Record Details
This FDA Inspection record concerns Industria Farmaceutica Andromaco S.A. de C.V., with an inspection on October 30, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 30, 2015
- Product Type
- Drugs
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ID · 9d296b6d-4cb3-447e-950a-88a7f56dba3d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953016
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Industria Farmaceutica Andromaco S.A. de C.V.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 1, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 1078693 - 2019-02-01
- FDA Inspection 1042708 - 2018-02-01
- FDA Inspection 786248 - 2012-06-01
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