FDA Inspection
Hospira, Inc.Hospira, Inc. – FDA Inspection, Apr 29, 2009
Record Details
This FDA Inspection record concerns Hospira, Inc., with an inspection on April 29, 2009, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Hospira, Inc.
- Inspection Date
- April 29, 2009
- Product Type
- Veterinary
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ID · b78c2b2f-ca90-49b9-880c-de2fe8ddb357
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 584062
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
FDA Citations
10- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.46(c)Air filtration system lacking in production area
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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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 |
| 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 |
| February 23, 2010 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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 649346 - 2010-02-23
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