Pharmacia and Upjohn Company, LLC
Form 483 issued October 9, 2013 · Kalamazoo, Michigan
- Inspection
- Sep 30 – Oct 9, 2013
- Investigators
- Danial S. Hutchison· Dawn C. Olenjack· Emily J. Orban
- Observations
- 10
- Pages
- 7
- FEI number
- 1810189
In short: On October 9, 2013, FDA issued a Form 483 with 10 observations to Pharmacia and Upjohn Company, LLC in Kalamazoo, Michigan (FEI 1810189) after an inspection that ran Sep 30 – Oct 9, 2013. The investigators were Danial S. Hutchison, Dawn C. Olenjack, Emily J. Orban and Jeffrey D. Meng. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 8 of 10 observations.
Most cited: 21 CFR 211.100 (4×) · 211.25 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
The ATNAA remediation process and visual inspection operators were not qualified to consistently detect and remove…
- 04
Written process validation protocols for the remediation of ATNAA…
This inspection in context
Danial S. Hutchison
2 documents · 2009–2013
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Michigan.
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
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 10 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Pharmacia and Upjohn Company, LLC?
Danial S. Hutchison, Dawn C. Olenjack, Emily J. Orban and Jeffrey D. Meng are named on this Form 483, for the inspection of Sep 30 – Oct 9, 2013. Each investigator has a profile showing what they cite most.
When was Pharmacia and Upjohn Company, LLC inspected by FDA?
The inspection ran Sep 30 – Oct 9, 2013, and the Form 483 is dated October 9, 2013.
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.