Drug factory · FDA FEI 3004713402
UBI Pharma Inc.
No. 45, Guangfu N. Rd., Hukou, Taiwan
Problems found, fixed voluntarily at FDA's last inspection, Jun 6, 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 2012: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acyclovir | Makes it | Solco Healthcare U.S., LLC | 43547-499 |
| Caspofungin | Makes it | Areva Pharmaceuticals, Inc. | 59923-613, 59923-614 |
| Cyanocobalamin | Makes it, tests it and packages it | Vitruvias Therapeutics, Inc. | 69680-112, 69680-113, 69680-121 |
| Desmopressin | Makes it, tests it and packages it | Dr. Reddy's Laboratories Inc., The J. Molner Company LLC, UBI Pharma Inc. | 43598-931, 83148-126, 83148-226 +3 |
| Epinephrine | Makes it, tests it and packages it | Baxter Healthcare Corporation | 43066-801, 43066-803 |
| Isopropyl Alcohol and Leuprolide | Makes it | UBI Pharma Inc. | 72843-591 |
| Naloxone | Makes it | Baxter Healthcare Corporation | 36000-308, 36000-310 |
| Norepinephrine | Makes it | Breckenridge Pharmaceutical, Inc. | 51991-983 |
| Olanzapine | Makes it | UBI Pharma Inc., XGen Pharmaceuticals DJB, Inc. | 72843-576, 39822-1800 |
| Terbutaline | Makes it | Areva Pharmaceuticals, Inc. | 59923-615 |
| Voriconazole | Makes it | UBI Pharma Inc. | 72843-441 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 6, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Jun 20, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 18, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 6, 2012 | 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.
Jun 6, 2023 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - 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, written and followed. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. - Laboratory Test Method Verification 21 CFR 211.194(a)(2)
Verification of the suitability of the testing methods is deficient in that they are not documented on the laboratory records. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture of a drug product lack the training required to perform their assigned functions. - Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
Registered with FDA for: analysis; manufacture; pack.