Drug factory · FDA FEI 3002721084
Teva Pharmaceutical Industries Ltd.
18 Eli Hurvitz Street, Industrial Zone, Kfar Saba, Israel
Problems found, fixed voluntarily at FDA's last inspection, May 23, 2023.
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 2009: 1 with no problems, 5 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 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 23, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Jul 25, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 15, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 18, 2013 | No problems found | Drug Quality Assurance | — |
| Aug 26, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 11, 2009 | Problems found, fixed voluntarily | 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.
May 23, 2023 inspection
- 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 and followed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Cleaning SOP/inspection 21 CFR 211.67(b)(6)
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.