Drug factory · FDA FEI 1000282452
Teva Czech Industries s.r.o.
305/29 Ostravska, Opava, Czech Republic
Problems found, fixed voluntarily at FDA's last inspection, Aug 30, 2024.
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: 2 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Pravastatin | Makes it, tests it, packages it and labels it | Aurobindo Pharma Limited | 84386-031, 84386-032, 84386-033 +1 |
| Propranolol | Makes it, tests it and packages it | Amneal Pharmaceuticals | 0115-1693 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 30, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 8, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 17, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 13, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 24, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 21, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 22, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 1, 2010 | 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.
Sep 22, 2011 inspection
- 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.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.