Lonza Bend Inc. — FDA Facility Profile

FEI 1000656789

Lonza Bend Inc. is an FDA-registered facility (FEI 1000656789) located in Bend, OR, US. Registered operations: ANALYSIS. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
May 19, 2026: Voluntary Action Indicated (VAI)
Inspections on record
4 (4 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 19, 2026Voluntary Action Indicated (VAI)Investigations of discrepancies, failures (21 CFR 211.192)
Aug 5, 2022Voluntary Action Indicated (VAI)Written program not followed (21 CFR 211.166(a))
Scientifically sound laboratory controls (21 CFR 211.160(b))
Written record of investigation incomplete (21 CFR 211.192)
Jun 30, 2017Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Control / Lab Operations Area (21 CFR 211.42(c)(9))
Scientifically sound laboratory controls (21 CFR 211.160(b))
Jun 3, 2016Voluntary Action Indicated (VAI)Approve or reject procedures or specs (21 CFR 211.22(c))
Computer control of master formula records (21 CFR 211.68(b))
Lab controls established, including changes (21 CFR 211.160(a))
Extent of discrepancy, failure investigations (21 CFR 211.192)

Facility details

Company
Lonza Bend Inc.
Location
Bend, OR (US)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS
Source
decrs

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.