FDA Inspection
Hospira, Inc.Hospira, Inc. – FDA Inspection, Feb 23, 2010
Record Details
This FDA Inspection record concerns Hospira, Inc., with an inspection on February 23, 2010, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Hospira, Inc.
- Inspection Date
- February 23, 2010
- Product Type
- Veterinary
View Company Profile
ID · c6b4c63b-c34c-4239-bc90-89b43214d412
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 649346
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
8- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 820.70(a)Production processes
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
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 |
| July 26, 2012 | VAI | 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 |
| 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 792357 - 2012-07-26
- FDA Inspection 771666 - 2012-03-09
- FDA Inspection 711591 - 2011-01-25
- FDA Inspection 584062 - 2009-04-29
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