FDA Inspection
Hospira Australia Pty Ltd.Hospira Australia Pty Ltd. – FDA Inspection, Apr 4, 2017
Record Details
This FDA Inspection record concerns Hospira Australia Pty Ltd., with an inspection on April 4, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
- Person
- Ileana Barreto-Pettit (Issuing Officer)
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ID · e29ff36f-1651-4151-8eff-e175442dfe2e
Inspection Facts
- Inspection number
- 1014024
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Hospira Australia Pty Ltd.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 2, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 15, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 4, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hospira Australia Pty Ltd.
- FDA Inspection 1181593 - 2022-09-02
- FDA Inspection 1100246 - 2019-07-02
- FDA Inspection 945591 - 2015-09-15
- FDA Inspection 869582 - 2014-03-04
- FDA Inspection 737223 - 2011-03-21
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