Drug factory · FDA FEI 1000656789

Lonza Bend Inc.

64550 Research Rd, 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.

4 drug inspections on record since 2016: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Lonafarnib	Tests it	Eiger BioPharmaceuticals, Inc.	73079-050, 73079-075

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	3
Jun 30, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	3
Jun 3, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	4

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Control / Lab Operations Area 21 CFR 211.42(c)(9)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls and operations.

Lab controls established, including changes 21 CFR 211.160(a)
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit.
Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy and 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.
Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
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.

Registered with FDA for: analysis.