Lonza Bend Inc.
Form 483 issued May 19, 2026 · Bend, Oregon
- Inspection
- May 12 – May 19, 2026
- Investigators
- Ana-Maria A. Plapcianu· Conor J. McCarron· Eric Zhu
- Observations
- 1
- Pages
- 4
- FEI number
- 3003722743
In short: On May 19, 2026, FDA issued a Form 483 with 1 observation to Lonza Bend Inc. in Bend, Oregon (FEI 3003722743) after an inspection that ran May 12 – May 19, 2026. The investigators were Ana-Maria A. Plapcianu, Conor J. McCarron, Eric Zhu and Roger F. Zabinski. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Ana-Maria A. Plapcianu
4 documents · 2020–2026
Cites 211.67 (equipment cleaning and maintenance) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lonza Bend Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Lonza Bend Inc.?
Ana-Maria A. Plapcianu, Conor J. McCarron, Eric Zhu and Roger F. Zabinski are named on this Form 483, for the inspection of May 12 – May 19, 2026. Each investigator has a profile showing what they cite most.
When was Lonza Bend Inc. inspected by FDA?
The inspection ran May 12 – May 19, 2026, and the Form 483 is dated May 19, 2026.
How do I get the full Form 483 for Lonza Bend Inc.?
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