FDA Inspection
Merck Serono S.p.A.Merck Serono S.p.A. – FDA Inspection, Sep 25, 2012
Record Details
This FDA Inspection record concerns Merck Serono S.p.A., with an inspection on September 25, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Merck Serono S.p.A.
- Inspection Date
- September 25, 2012
- Product Type
- Drugs
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ID · 647a3bfc-7805-4288-842d-9523c713e3b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 802081
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Merck Serono S.p.A.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2023 | Not classified | Office of Inspections and Investigations | |
| March 17, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 31, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 22, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 25, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Merck Serono S.p.A.
- FDA Inspection 1222768 - 2023-05-10
- FDA Inspection 1215892 - 2023-03-17
- FDA Inspection 1091595 - 2019-05-31
- FDA Inspection 1118104 - 2018-06-22
- FDA Inspection 1053903 - 2018-05-25
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