Drug factory · FDA FEI 3005363495

Quinta-Analytica s.r.o.

Prazska 1486/18c, Prague 10, Czech Republic

Problems found, fixed voluntarily at FDA's last inspection, Mar 6, 2025.

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 2009: 2 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Darolutamide	Tests it	Bayer HealthCare Pharmaceuticals Inc.	50419-395
Elafibranor	Tests it	Ipsen Biopharmaceuticals, Inc.	15054-0080

Ended	Result	Program	Problems noted
Mar 6, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 10, 2025	Problems found, fixed voluntarily	Bioresearch Monitoring	—
Nov 3, 2022	Problems found, fixed voluntarily	Bioresearch Monitoring	—
Apr 20, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 16, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 5, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	3
Mar 27, 2013	No problems found	Drug Quality Assurance	—
Jun 2, 2009	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.
Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Test methods 21 CFR 211.165(e)
The accuracy and sensitivity of test methods have not been established and documented.

Registered with FDA for: analysis.