FDA Inspection
Hospira, Inc.Hospira, Inc. – FDA Inspection, Jan 19, 2010
Record Details
This FDA Inspection record concerns Hospira, Inc., with an inspection on January 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hospira, Inc.
- Inspection Date
- January 19, 2010
- Product Type
- Devices
View Company Profile
ID · a86b587d-3897-42cd-88ee-22ff5cebd21a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 639034
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 820.100(a)(6)Dissemination of problem information
- 21 CFR 211.110(b)In-process materials specifications
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.70(a)Production processes
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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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