FDA Inspection
Grisi Hnos, S.A. de C.V.Grisi Hnos, S.A. de C.V. – FDA Inspection, Nov 29, 2012
Record Details
This FDA Inspection record concerns Grisi Hnos, S.A. de C.V., with an inspection on November 29, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Grisi Hnos, S.A. de C.V.
- Inspection Date
- November 29, 2012
- Product Type
- Drugs
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ID · 8314fcf1-0d18-483d-8631-bbe2564cae71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810860
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| February 23, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 20, 2015 | 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 1042002 - 2018-02-23
- FDA Inspection 926456 - 2015-05-20
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