Pharmacia and Upjohn Company, LLC
Form 483 issued December 10, 2018 · Kalamazoo, Michigan
- Inspection
- Nov 26 – Dec 10, 2018
- Investigators
- David Gasparovich· Thomas A. Peter
- Observations
- 7
- Pages
- 11
- FEI number
- 1810189
In short: On December 10, 2018, FDA issued a Form 483 with 7 observations to Pharmacia and Upjohn Company, LLC in Kalamazoo, Michigan (FEI 1810189) after an inspection that ran Nov 26 – Dec 10, 2018. The investigators were David Gasparovich and Thomas A. Peter. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
- 0421 CFR 820
Procedures for quality audits have…
This inspection in context
David Gasparovich
8 documents · 2015–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Illinois.
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 820.100(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 cAPA, production & process controls and management controls. The opening words of each observation are shown on this page.
Who inspected Pharmacia and Upjohn Company, LLC?
David Gasparovich and Thomas A. Peter are named on this Form 483, for the inspection of Nov 26 – Dec 10, 2018. Each investigator has a profile showing what they cite most.
When was Pharmacia and Upjohn Company, LLC inspected by FDA?
The inspection ran Nov 26 – Dec 10, 2018, and the Form 483 is dated December 10, 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.