Drug factory · FDA FEI 3007102377
Fresenius Medical Care de Mexico, S.A. de C.V.
Paseo del Norte No. 5300, Zapopan, Mexico
Problems found, fixed voluntarily at FDA's last inspection, Dec 4, 2018.
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 2009: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Anhydrous Citric Acid | Makes it, tests it, packages it, labels it and sterilizes it | Fenwal, Inc. | 0942-9506 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 4, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 26, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 17, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 30, 2009 | 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 26, 2016 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 written.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.