Pharmacia and Upjohn Company, LLC
Form 483 issued June 16, 2023 · Kalamazoo, Michigan
- Inspection
- Jun 5 – Jun 16, 2023
- Investigators
- Gene D. Arcy· Jacob G. Lutz
- Observations
- 7
- Pages
- 7
- FEI number
- 1810189
In short: On June 16, 2023, FDA issued a Form 483 with 7 observations to Pharmacia and Upjohn Company, LLC in Kalamazoo, Michigan (FEI 1810189) after an inspection that ran Jun 5 – Jun 16, 2023. The investigators were Gene D. Arcy and Jacob G. Lutz. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 03
The quality control unit lacks authority to review production records to assure that…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Gene D. Arcy
16 documents · 2003–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmPharmacia and Upjohn Company, LLC history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmacia and Upjohn Company, LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Pharmacia and Upjohn Company, LLC?
Gene D. Arcy and Jacob G. Lutz are named on this Form 483, for the inspection of Jun 5 – Jun 16, 2023. Each investigator has a profile showing what they cite most.
When was Pharmacia and Upjohn Company, LLC inspected by FDA?
The inspection ran Jun 5 – Jun 16, 2023, and the Form 483 is dated June 16, 2023.
How do I get the full Form 483 for Pharmacia and Upjohn Company, LLC?
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