Pharmacia and Upjohn Company, LLC
Form 483 issued May 20, 2021 · Kalamazoo, Michigan
- Inspection
- May 11 – May 20, 2021
- Investigator
- Janet L. Bowen
- Observations
- 4
- Pages
- 5
- FEI number
- 1810189
In short: On May 20, 2021, FDA issued a Form 483 with 4 observations to Pharmacia and Upjohn Company, LLC in Kalamazoo, Michigan (FEI 1810189) after an inspection that ran May 11 – May 20, 2021. The investigator was Janet L. Bowen. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.130 (packaging and labeling operations).
At a glance
Quality system and packaging & labeling account for 3 of 4 observations.
Most cited: 21 CFR 211.192 (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
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Changes to written procedures were not reviewed and approved by…
This inspection in context
Janet L. Bowen
4 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
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 4 observations on this Form 483, mostly about quality system, packaging & labeling and production. The most-cited regulation is 21 CFR 211.130 (packaging and labeling operations). The opening words of each observation are shown on this page.
Who inspected Pharmacia and Upjohn Company, LLC?
Janet L. Bowen is named on this Form 483, for the inspection of May 11 – May 20, 2021. Each investigator has a profile showing what they cite most.
When was Pharmacia and Upjohn Company, LLC inspected by FDA?
The inspection ran May 11 – May 20, 2021, and the Form 483 is dated May 20, 2021.
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.