Drug factory · FDA FEI 3002367943

Quality Assistance, SA

Technoparc de Thudinie 2, Donstiennes, Belgium

Problems found, fixed voluntarily at FDA's last inspection, Sep 4, 2025.

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 2010: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Isatuximab	Tests it	Sanofi-Aventis U.S. LLC	0024-0654, 0024-0656

Ended	Result	Program	Problems noted
Sep 4, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 12, 2021	No problems found	Drug Quality Assurance	—
Sep 17, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	4
Jun 4, 2014	No problems found	Drug Quality Assurance	—
Feb 16, 2010	No problems found	Drug Quality Assurance	—

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

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 drug products conform to appropriate standards of identity, strength, quality and purity.
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.
Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
input/output verification 21 CFR 211.68(b)
Input to and output from the computer and records or data are not checked for accuracy.

Registered with FDA for: analysis.