Lonza Bend Inc.
Form 483 issued August 5, 2022 · Bend, Oregon
- Inspection
- Jul 25 – Aug 5, 2022
- Investigators
- Crystal Monroy· Nathaniel B. Phillips-Sylvain
- Observations
- 1
- Pages
- 3
- FEI number
- 3003722743
In short: On August 5, 2022, FDA issued a Form 483 with 1 observation to Lonza Bend Inc. in Bend, Oregon (FEI 3003722743) after an inspection that ran Jul 25 – Aug 5, 2022. The investigators were Crystal Monroy and Nathaniel B. Phillips-Sylvain. 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
Investigations of an unexplained discrepancy did not extend to other batches of…
This inspection in context
Crystal Monroy
15 documents · 2014–2026
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 211.192
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.?
Crystal Monroy and Nathaniel B. Phillips-Sylvain are named on this Form 483, for the inspection of Jul 25 – Aug 5, 2022. Each investigator has a profile showing what they cite most.
When was Lonza Bend Inc. inspected by FDA?
The inspection ran Jul 25 – Aug 5, 2022, and the Form 483 is dated August 5, 2022.
How do I get the full Form 483 for Lonza Bend Inc.?
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