FDA Inspection
Zydus Hospira Oncology Private Ltd.Zydus Hospira Oncology Private Ltd. – FDA Inspection, Oct 22, 2019
Record Details
This FDA Inspection record concerns Zydus Hospira Oncology Private Ltd., with an inspection on October 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 22, 2019
- Product Type
- Drugs
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ID · 45367c8e-d0a9-4d85-98cc-02abfd4cebe6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1107385
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Zydus Hospira Oncology Private Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 12, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 16, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Zydus Hospira Oncology Private Ltd.
- FDA Inspection 1209538 - 2023-06-30
- FDA Inspection 1048779 - 2018-04-12
- FDA Inspection 899318 - 2014-09-16
- FDA Inspection 794202 - 2012-07-26
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