Lonza Bend Inc.
Form 483 issued May 24, 2023 · Bend, Oregon
- Inspection
- May 17 – May 24, 2023
- Investigator
- Hung H. Do
- Observations
- 3
- Pages
- 5
- FEI number
- 3003722743
In short: On May 24, 2023, FDA issued a Form 483 with 3 observations to Lonza Bend Inc. in Bend, Oregon (FEI 3003722743) after an inspection that ran May 17 – May 24, 2023. The investigator was Hung H. Do. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and materials account for 2 of 3 observations.
Most cited: 21 CFR 211.68 (1×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Drug product component testing is deficient in that at least one specific test to verify the…
This inspection in context
Hung H. Do
11 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
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 211.68
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 facilities & equipment and materials. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Lonza Bend Inc.?
Hung H. Do is named on this Form 483, for the inspection of May 17 – May 24, 2023. Each investigator has a profile showing what they cite most.
When was Lonza Bend Inc. inspected by FDA?
The inspection ran May 17 – May 24, 2023, and the Form 483 is dated May 24, 2023.
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.