Drug factory · FDA FEI 3010600744
Infomed Fluids SRL
B-DUL THEODOR PALLADY NR. 50, SECTORUL 3, , Bucuresti, Romania
Problems found, fixed voluntarily at FDA's last inspection, Apr 7, 2023.
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 2015: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ciprofloxacin | Makes it, tests it, packages it, labels it and sterilizes it | Hospira, Inc. | 0409-2300, 0409-3300 |
| Fluconazole | Makes it, tests it, packages it, labels it and sterilizes it | Hospira, Inc. | 0409-3435, 0409-4321 |
| Levofloxacin | Makes it, tests it, packages it, labels it and sterilizes it | Hospira, Inc. | 0409-2220, 0409-3330, 0409-4444 |
| Magnesium Cation | Makes it | WG Critical Care, LLC. | 44567-160, 44567-410 |
| Metronidazole | Makes it | Hospira, Inc., WG Critical Care, LLC. | 0409-0152, 44567-750 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 7, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 28, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 3, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Jan 20, 2015 | 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.
Mar 3, 2017 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that components conform to appropriate standards of identity, strength, quality and purity. - Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed. - 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. - 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. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.