Lonza Bend Inc. — FDA Facility Profile
Lonza Bend Inc. is an FDA-registered facility (FEI 3003722743) located in Bend, OR, US. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 5 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
- 5 (5 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
- Form 483 and inspection documents
- 1 in FDA's reading room
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 19, 2026 | Voluntary Action Indicated (VAI) | Investigations of discrepancies, failures (21 CFR 211.192) |
| Aug 5, 2022 | Voluntary Action Indicated (VAI) | Extent of discrepancy, failure investigations (21 CFR 211.192) |
| Jul 21, 2017 | Voluntary Action Indicated (VAI) | No citations listed |
| Jun 3, 2016 | Voluntary Action Indicated (VAI) | Authority lacking to review records, investigate errors (21 CFR 211.22(a)) Procedures not in writing, fully followed (21 CFR 211.22(d)) Training--operations, GMPs, written procedures (21 CFR 211.25(a)) Computer control of master formula records (21 CFR 211.68(b)) and 3 more |
| Jun 3, 2016 | Voluntary Action Indicated (VAI) | Protection from external factors (21 CFR 211.94(b)) |
Form 483s and inspection documents
- May 19, 2026: 483 on FDA.gov
Facility details
- Company
- Lonza Bend Inc.
- Location
- Bend, OR (US)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; MANUFACTURE
- Source
- decrs