Drug factory · FDA FEI 1122041

Bioreliance Corporation

9820 Darnestown Road, Rockville, MD, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

Problems found, fixed voluntarily at FDA's last inspection, Jan 29, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

14 drug inspections on record since 2009: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Tocilizumab	Tests it	Biogen MA Inc.	64406-022, 64406-023

Ended	Result	Program	Problems noted
Jan 29, 2026	Problems found, fixed voluntarily	Bioresearch Monitoring	4
Jan 29, 2026	Problems found, fixed voluntarily	Bioresearch Monitoring	4
Aug 4, 2023	No problems found	Drug Quality Assurance	—
Aug 4, 2023	No problems found	Drug Quality Assurance	—
Jul 13, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 13, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 11, 2016	No problems found	Drug Quality Assurance	—
Jan 11, 2016	No problems found	Drug Quality Assurance	—
May 14, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 14, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 3, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	8
Jul 3, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	8
Feb 18, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 18, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—

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

Study director: follow study protocol 21 CFR 58.33(a)
The study director failed to assure that the protocol, including any change, was approved and was followed.
Study director: follow study protocol 21 CFR 58.33(a)
The study director failed to assure that the protocol, including any change, was approved and was followed.
Study director: unforeseen circumstances 21 CFR 58.33(c)
The study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study were noted when they occurred and corrective action was taken and documented.
Study director: unforeseen circumstances 21 CFR 58.33(c)
The study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study were noted when they occurred and corrective action was taken and documented.

Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written standards are not justified.
Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures are not followed.
Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written standards are not justified.
Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures are not followed.
Data secured in course of each test 21 CFR 211.194(a)(4)
Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the drug product tested.
Data secured in course of each test 21 CFR 211.194(a)(4)
Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the drug product tested.
input/output verification 21 CFR 211.68(b)
Input to and output from the computer and related systems of formulas are not checked for accuracy.
input/output verification 21 CFR 211.68(b)
Input to and output from the computer and related systems of formulas are not checked for accuracy.

Registered with FDA for: analysis.