Drug factory · FDA FEI 3003492806
Opella Healthcare International Sas
56 Route de Choisy, Compiegne, France
Problems found, fixed voluntarily at FDA's last inspection, Jan 10, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2011: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Glyburide | Makes it and tests it | Teva Pharmaceuticals USA, Inc. | 0093-9364, 0093-9433, 0093-9477 |
| Leflunomide | Makes it, tests it, packages it and labels it | sanofi-aventis U.S. LLC | 0088-2160, 0088-2161, 0088-2162 |
| Teriflunomide | Makes it, tests it, packages it and labels it | Genzyme Corporation | 58468-0210, 58468-0211 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 10, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 31, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 23, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Sep 18, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Sep 19, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 21, 2011 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 23, 2017 inspection
- Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed. - Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing and packing of a drug product lack the training required to perform their assigned functions. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Sep 18, 2015 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed. - 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 in-process materials conform to appropriate standards of identity, strength, quality and purity. - Annual visual exams of drug products 21 CFR 211.170(b)
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration. - 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. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.