Pharmacia and Upjohn Company, LLC
Form 483 issued July 9, 2015 · Kalamazoo, Michigan
- Inspection
- Jun 23 – Jul 9, 2015
- Investigators
- Andrew J. Idzior· Jeffrey D. Meng· Rebecca E. Dombrowski
- Observations
- 8
- Pages
- 5
- FEI number
- 1810189
In short: On July 9, 2015, FDA issued a Form 483 with 8 observations to Pharmacia and Upjohn Company, LLC in Kalamazoo, Michigan (FEI 1810189) after an inspection that ran Jun 23 – Jul 9, 2015. The investigators were Andrew J. Idzior, Jeffrey D. Meng and Rebecca E. Dombrowski. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Documented investigations into discrepancies and out-of-specification results…
- 02
Annual product reviews do not include a review of all appropriate data to evaluate quality characteristics…
- 03
Equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate…
- 04
Individual logs for major equipment do not include…
This inspection in context
Andrew J. Idzior
6 documents · 2013–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.192
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 8 observations on this Form 483, mostly about quality system, materials and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Pharmacia and Upjohn Company, LLC?
Andrew J. Idzior, Jeffrey D. Meng and Rebecca E. Dombrowski are named on this Form 483, for the inspection of Jun 23 – Jul 9, 2015. Each investigator has a profile showing what they cite most.
When was Pharmacia and Upjohn Company, LLC inspected by FDA?
The inspection ran Jun 23 – Jul 9, 2015, and the Form 483 is dated July 9, 2015.
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.