Lonza Bend Inc.
Form 483 issued July 27, 2018 · Bend, Oregon
- Inspection
- Jan 23 – Jul 27, 2018
- Investigators
- Chiaochun J. Wang· Zachary A. Bogorad
- Observations
- 3
- Pages
- 6
- FEI number
- 3003722743
In short: On July 27, 2018, FDA issued a Form 483 with 3 observations to Lonza Bend Inc. in Bend, Oregon (FEI 3003722743) after an inspection that ran Jan 23 – Jul 27, 2018. The investigators were Chiaochun J. Wang and Zachary A. Bogorad. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Chiaochun J. Wang
2 documents · 2018
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmLonza Bend Inc. history
All 4 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 Lonza Bend Inc.?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Lonza Bend Inc.?
Chiaochun J. Wang and Zachary A. Bogorad are named on this Form 483, for the inspection of Jan 23 – Jul 27, 2018. Each investigator has a profile showing what they cite most.
When was Lonza Bend Inc. inspected by FDA?
The inspection ran Jan 23 – Jul 27, 2018, and the Form 483 is dated July 27, 2018.
How do I get the full Form 483 for Lonza Bend Inc.?
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.