Drug factory · FDA FEI 3007388138

Cenexi - Laboratoires Thissen Sa

Rue de la Papyrée, 2-4-6, Braine l'Alleud, Belgium

Problems found, fixed voluntarily at FDA's last inspection, Jun 1, 2023.

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

8 drug inspections on record since 2010: 1 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Ended	Result	Program	Problems noted
Jun 1, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 6, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	7
Feb 19, 2020	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 16, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 18, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 4, 2014	No problems found	Drug Quality Assurance	—
Jul 17, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 11, 2010	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.

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures are not followed.
Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been documented.
Failing drug products not rejected 21 CFR 211.165(f)
Drug products failing to meet established quality control criteria are not rejected.
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.
Inadequate number of personnel 21 CFR 211.25(c)
The number of qualified personnel is inadequate to the processing of each drug product.
Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the processing of a drug product are not maintained in a good state of repair.

Registered with FDA for: analysis; label; manufacture; pack; sterilize.