FDA Inspection
Sagent PharmaceuticalsSagent Pharmaceuticals – FDA Inspection, Sep 24, 2018
Record Details
This FDA Inspection record concerns Sagent Pharmaceuticals, with an inspection on September 24, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Debra L. Boyd Seale (Issuing Officer)
- Lequita M. Mayhew (Issuing Officer)
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ID · db728d61-25fd-4a30-a263-c89969ba55cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066792
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 314.81(b)(2)(i)Summary
- 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
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Sagent Pharmaceuticals
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 19, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 11, 2012 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 11, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sagent Pharmaceuticals
- FDA Inspection 1231342 - 2024-09-20
- FDA Inspection 1114257 - 2019-12-18
- FDA Inspection 940865 - 2015-08-19
- FDA Inspection 782558 - 2012-05-11
- FDA Inspection 717757 - 2011-03-11
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