FDA Inspection
Schwabe Mexico S.A. de C.V.Schwabe Mexico S.A. de C.V. – FDA Inspection, Sep 8, 2017
Record Details
This FDA Inspection record concerns Schwabe Mexico S.A. de C.V., with an inspection on September 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f2d66066-87d4-490b-9add-e541e0d7e66c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024500
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of Schwabe Mexico S.A. de C.V.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Schwabe Mexico S.A. de C.V.
- FDA Inspection 895257 - 2014-09-05
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