FDA Inspection
Hospira, Inc.Hospira, Inc. – FDA Inspection, Mar 1, 2013
Record Details
This FDA Inspection record concerns Hospira, Inc., with an inspection on March 1, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hospira, Inc.
- Inspection Date
- March 1, 2013
- Product Type
- Drugs
View Company Profile
ID · b036e318-0000-47d8-8b5d-24bfab812f15
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 833823
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
20- 21 CFR 211.42(c)(10)(ii)Temperature / Humidity Controls
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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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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