FDA Inspection
Merck Sante s.a.sMerck Sante s.a.s – FDA Inspection, Jun 17, 2013
Record Details
This FDA Inspection record concerns Merck Sante s.a.s, with an inspection on June 17, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Merck Sante s.a.s
- Inspection Date
- June 17, 2013
- Product Type
- Drugs
View Company Profile
ID · ce77d43f-85d6-4360-8470-440756a760bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 842828
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Merck Sante s.a.s
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2024 | Not classified | Office of Inspections and Investigations | |
| June 14, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Merck Sante s.a.s
- FDA Inspection 1270283 - 2024-10-25
- FDA Inspection 1060260 - 2018-06-14
- FDA Inspection 990190 - 2016-06-21
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