FDA Inspection
Hospira, Inc.Hospira, Inc. – FDA Inspection, Jun 17, 2011
Record Details
This FDA Inspection record concerns Hospira, Inc., with an inspection on June 17, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hospira, Inc.
- Inspection Date
- June 17, 2011
- Product Type
- Drugs
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ID · c3ca52ef-1c47-48ea-943d-8ae7fe6e1334
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 732886
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
Showing 10 of 17 citations.
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Other FDA inspections of Hospira, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2025 | Not classified | Atlanta District Office | |
| November 14, 2023 | OAI | Atlanta District Office | |
| November 21, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 2, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 26, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hospira, Inc.
- FDA Inspection 1251941 - 2025-02-07
- FDA Inspection 1223090 - 2023-11-14
- FDA Inspection 1110899 - 2019-11-21
- FDA Inspection 1039547 - 2018-02-02
- FDA Inspection 984874 - 2016-05-26
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