Pharmacia and Upjohn Company, LLC
FDA inspection history in Kalamazoo, Michigan, 2013 to 2023
- 7
- Form 483s
Every document, by year
- Form 483
2013: one Form 483; 2015: one Form 483; 2017: one Form 483; 2018: two Form 483s; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–18Five Form 483s, at Kalamazoo, Michigan.
- 2013The longest 483 on file: 10 observations over 7 pages at Kalamazoo, Michigan.
- 2021–23Two Form 483s, at Kalamazoo, Michigan.
Cited most
Across all Pharmacia and Upjohn Company observations on file
- 21 CFR 211.100Written procedures; deviations7
- 21 CFR 211.192Production record review5
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.25Personnel qualifications3
The complete Pharmacia and Upjohn Company file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Kalamazoo, Michigan
Seven Form 483s · 2013 to 2023 · 45 observations
Latest: Form 483, Jun 16, 2023 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-16 | 483 Form 483 | Kalamazoo, Michigan | 7 | $99 |
| 2021-05-20 | 483 Form 483 | Kalamazoo, Michigan | 4 | $99 |
| 2018-12-10 | 483 Form 483 | Kalamazoo, Michigan | 7 | $99 |
| 2018-09-21 | 483 Form 483 | Kalamazoo, Michigan | 3 | $99 |
| 2017-12-22 | 483 Form 483 | Kalamazoo, Michigan | 6 | $99 |
| 2015-07-09 | 483 Form 483 | Kalamazoo, Michigan | 8 | $99 |
| 2013-10-09 | 483 Form 483 | Kalamazoo, Michigan | 10 | $99 |
Investigators on these documents
Jeffrey D. Meng (2)Thomas A. Peter (2)David Gasparovich (1)Dawn C. Olenjack (1)Emily J. Orban (1)Gene D. Arcy (1)Andrew J. Idzior (1)James K. Ireland (1)Janet L. Bowen (1)Rebecca E. Dombrowski (1)Sarah E. Rhoades (1)Jacob G. Lutz (1)
FEI number 1810189 · most recent document Jun 16, 2023
About Pharmacia and Upjohn Company, LLC
How many FDA Form 483s has Pharmacia and Upjohn Company, LLC received?
FDA Intel has 7 Form 483s on file for Pharmacia and Upjohn Company, LLC; the most recent is dated Jun 16, 2023.
When was Pharmacia and Upjohn Company, LLC last inspected by FDA?
The most recent FDA inspection document on file for Pharmacia and Upjohn Company, LLC is a Form 483 dated Jun 16, 2023, for the site in Kalamazoo, Michigan.
What did FDA cite at Pharmacia and Upjohn Company, LLC?
The regulations cited most in the observations on file for Pharmacia and Upjohn Company, LLC are 21 CFR 211.100 (Written procedures; deviations), 7 times; 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times.