Drug factory · FDA FEI 3003722743
Lonza Bend Inc.
20503 Builders St, Bend, OR, United States
Problems found, fixed voluntarily at FDA's last inspection, May 19, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2016: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Levoketoconazole | Tests it | Xeris Pharmaceuticals, Inc. | 72065-003 |
| Lonafarnib | Makes it | Eiger BioPharmaceuticals, Inc. | 73079-050, 73079-075 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 19, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 5, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jul 21, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 3, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
| Jun 3, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 19, 2026 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Aug 5, 2022 inspection
- Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product.
Jun 3, 2016 inspection
- Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. - Quality Control Review 21 CFR 211.198(a)
Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation by the quality control unit. - Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices and written procedures required by current good manufacturing practice regulations. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. - Protection from external factors 21 CFR 211.94(b)
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
Jun 3, 2016 inspection
- Protection from external factors 21 CFR 211.94(b)
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
Registered with FDA for: analysis; manufacture.