Pharmacia and Upjohn Company, LLC
Form 483 issued September 21, 2018 · Kalamazoo, Michigan
- Inspection
- Sep 21, 2018
- Investigators
- James K. Ireland· Sarah E. Rhoades
- Observations
- 3
- Pages
- 4
- FEI number
- 1810189
In short: On September 21, 2018, FDA issued a Form 483 with 3 observations to Pharmacia and Upjohn Company, LLC in Kalamazoo, Michigan (FEI 1810189) after an inspection that ran Sep 21, 2018. The investigators were James K. Ireland and Sarah E. Rhoades. Most observations concern production and quality system.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Employees are not given training in the particular operations they perform as…
- 03
Deviations from written production and process control…
This inspection in context
James K. Ireland
10 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
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 211.113
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 3 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected Pharmacia and Upjohn Company, LLC?
James K. Ireland and Sarah E. Rhoades are named on this Form 483, for the inspection of Sep 21, 2018. Each investigator has a profile showing what they cite most.
When was Pharmacia and Upjohn Company, LLC inspected by FDA?
The inspection ran Sep 21, 2018, and the Form 483 is dated September 21, 2018.
How do I get the full Form 483 for Pharmacia and Upjohn Company, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.