FDA Inspection
Hospira, Inc.Hospira, Inc. – FDA Inspection, Jul 26, 2012
Record Details
This FDA Inspection record concerns Hospira, Inc., with an inspection on July 26, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hospira, Inc.
- Inspection Date
- July 26, 2012
- Product Type
- Drugs
View Company Profile
ID · 12b1a35a-c6f7-4e9c-9d46-e7eb41e14184
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 792357
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Hospira, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 9, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 25, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 23, 2010 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 29, 2009 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
Other documents for Hospira, Inc.
- FDA Inspection 839531 - 2013-06-13
- FDA Inspection 771666 - 2012-03-09
- FDA Inspection 711591 - 2011-01-25
- FDA Inspection 649346 - 2010-02-23
- FDA Inspection 584062 - 2009-04-29
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