FDA Inspection
Pharmacia & Upjohn Company LLCPharmacia & Upjohn Company LLC – FDA Inspection, Dec 22, 2017
Record Details
This FDA Inspection record concerns Pharmacia & Upjohn Company LLC, with an inspection on December 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6c56382d-6f9e-4991-ab9e-80a0343e7cb4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1036094
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate 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 |
| September 21, 2018 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
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 1066512 - 2018-09-21
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