Drug factory · FDA FEI 2245641
Teva Pharmaceuticals USA, Inc.
8-10 Gloria Lane, Fairfield, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 20, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2010: 4 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydralazine | Makes it | Mylan Institutional Inc. | 51079-074, 51079-075, 51079-076 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 20, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 10, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 11, 2018 | No problems found | Drug Quality Assurance | — |
| Feb 1, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 6, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 30, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 19, 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.
Jul 20, 2026 inspection
- In-process materials characteristics testing 21 CFR 211.110(c)
In-process materials are not tested for strength, quality and purity and approved or rejected by the quality control unit after storage for long periods.
Nov 10, 2022 inspection
- Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not recorded and justified. - 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. - 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.
Feb 1, 2017 inspection
- Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; label; manufacture; pack.