FDA Inspection
Zydus Hospira Oncology Private Ltd.Zydus Hospira Oncology Private Ltd. – FDA Inspection, Apr 12, 2018
Record Details
This FDA Inspection record concerns Zydus Hospira Oncology Private Ltd., with an inspection on April 12, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Vilmary Negron Rodriguez (Issuing Officer)
View Company Profile
ID · 5353f90a-015e-4e40-905f-ca883f90d753
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048779
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
Full citation text and observation details available on the Dashboard.
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 |
| October 22, 2019 | 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 1107385 - 2019-10-22
- FDA Inspection 899318 - 2014-09-16
- FDA Inspection 794202 - 2012-07-26
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.