Pharmacia and Upjohn Company, LLC
Form 483 issued December 22, 2017 · Kalamazoo, Michigan
- Inspection
- Dec 18 – Dec 22, 2017
- Investigator
- Thomas A. Peter
- Observations
- 6
- Pages
- 6
- FEI number
- 1810189
In short: On December 22, 2017, FDA issued a Form 483 with 6 observations to Pharmacia and Upjohn Company, LLC in Kalamazoo, Michigan (FEI 1810189) after an inspection that ran Dec 18 – Dec 22, 2017. The investigator was Thomas A. Peter. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change have…
- 02
Procedures for collective and preventive action have…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
Procedures have not been adequately established to control product that does not…
This inspection in context
Thomas A. Peter
9 documents · 2011–2019
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Indiana.
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 820.30(i)
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 6 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Pharmacia and Upjohn Company, LLC?
Thomas A. Peter is named on this Form 483, for the inspection of Dec 18 – Dec 22, 2017. Each investigator has a profile showing what they cite most.
When was Pharmacia and Upjohn Company, LLC inspected by FDA?
The inspection ran Dec 18 – Dec 22, 2017, and the Form 483 is dated December 22, 2017.
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.