FDA Inspection
Merck Sante s.a.sMerck Sante s.a.s – FDA Inspection, Jun 21, 2016
Record Details
This FDA Inspection record concerns Merck Sante s.a.s, with an inspection on June 21, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Merck Sante s.a.s
- Inspection Date
- June 21, 2016
- Product Type
- Drugs
View Company Profile
ID · 117dec16-c4c0-42ea-a74c-f2083f3a6214
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 990190
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
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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 17, 2013 | 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 842828 - 2013-06-17
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