FDA Inspection
Pharmacia & Upjohn Company LLCPharmacia & Upjohn Company LLC – FDA Inspection, Sep 21, 2018
Record Details
This FDA Inspection record concerns Pharmacia & Upjohn Company LLC, with an inspection on September 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Emily J. Stoklosa (Issuing Officer)
- James K. Ireland (FDA Associated Person)
- Sarah E. Rhoades (FDA Associated Person)
- Scott A. Golladay
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ID · b06852cb-94b5-43f9-8313-ba3a90461cb4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066512
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
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Other FDA inspections of Pharmacia & Upjohn Company LLC
17| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2026 | Not classified | Detroit District Office | Blood and Blood Products |
| June 16, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 20, 2021 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| December 10, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 22, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pharmacia & Upjohn Company LLC
- FDA Inspection 1295014 - 2026-09-29
- FDA Inspection 1208260 - 2023-06-16
- FDA Inspection 1143004 - 2021-05-20
- FDA Inspection 1074087 - 2018-12-10
- FDA Inspection 1036094 - 2017-12-22
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