FDA Inspection
Hospira, Inc., A Pfizer CompanyHospira, Inc., A Pfizer Company – FDA Inspection, Jan 17, 2020
Record Details
This FDA Inspection record concerns Hospira, Inc., A Pfizer Company, with an inspection on January 17, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 17, 2020
- Product Type
- Drugs
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ID · 39385f66-71df-45ae-876a-f6026e6f413f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1115467
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.46(c)Exhaust systems inadequate to control air contamination
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.110(b)In-process conformity - examination, sample testing
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Other FDA inspections of Hospira, Inc., A Pfizer Company
19| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2026 | Not classified | Kansas City District Office | |
| January 17, 2025 | VAI | Kansas City District Office | Drug Quality Assurance |
| March 27, 2024 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 30, 2023 | Not classified | Kansas City District Office | |
| August 15, 2018 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Hospira, Inc., A Pfizer Company
- FDA Inspection 1310592 - 2026-03-10
- FDA Inspection 1255699 - 2025-01-17
- FDA Inspection 1229140 - 2024-03-27
- FDA Inspection 1209308 - 2023-06-30
- FDA Inspection 1064827 - 2018-08-15
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