Drug factory · FDA FEI 3002807925
Bayer de Mexico, S.A. de C.V.
Av. Reforma No. 46 Potrerillo, Ixtaczoquitlan Veracruz, Mexico
Problems found, fixed voluntarily at FDA's last inspection, Jun 5, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2010: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Testosterone | Makes the active ingredient | Antares Pharma, Inc. | 54436-200, 54436-250, 54436-275 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 5, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 25, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 14, 2014 | No problems found | Drug Quality Assurance | — |
| Nov 5, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.