FDA Inspection
Sanofi US Services, Inc.Sanofi US Services, Inc. – FDA Inspection, May 13, 2010
Record Details
This FDA Inspection record concerns Sanofi US Services, Inc., with an inspection on May 13, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sanofi US Services, Inc.
- Inspection Date
- May 13, 2010
- Product Type
- Drugs
View Company Profile
ID · 7e660b16-b5fd-4649-bae6-3a84e01b90f1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 661423
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 314.81(b)(2)(viii)Post marketing study status report for other studies
- 21 CFR 314.81(b)(2)(vi)(b)Completed, unpublished clinical trials
- 21 CFR 314.80(c)(1)(ii)Submission of report follow-up
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
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Other FDA inspections of Sanofi US Services, Inc.
15| Date | Classification | Office | Project area |
|---|---|---|---|
| October 23, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 28, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 1, 2021 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 9, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 3, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Sanofi US Services, Inc.
- FDA Inspection 1235539 - 2024-10-23
- FDA Inspection 1230103 - 2024-02-28
- FDA Inspection 1156765 - 2021-10-01
- FDA Inspection 1074575 - 2018-10-09
- FDA Inspection 987709 - 2016-08-03
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