FDA Inspection
Grisi Hnos, S.A. de C.V.Grisi Hnos, S.A. de C.V. – FDA Inspection, Feb 23, 2018
Record Details
This FDA Inspection record concerns Grisi Hnos, S.A. de C.V., with an inspection on February 23, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d1c6eb2e-234a-457b-968b-6fe66a8a5eb9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042002
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
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Other FDA inspections of Grisi Hnos, S.A. de C.V.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 21, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 20, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 29, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Grisi Hnos, S.A. de C.V.
- FDA Inspection 1181885 - 2022-10-21
- FDA Inspection 926456 - 2015-05-20
- FDA Inspection 810860 - 2012-11-29
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