Drug factory · FDA FEI 3005508367
Laboratorios Liconsa SAU
Avenida Miralcampo 7, Polígono Industrial Miralcampo, Azuqueca De Henares, Spain
Problems found, fixed voluntarily at FDA's last inspection, Jan 17, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2010: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acyclovir | Makes it | Xiromed, LLC. | 70700-107 |
| Betamethasone | Makes it | Xiromed, LLC. | 70700-141 |
| Fluocinonide | Makes it | Xiromed, LLC. | 70700-146 |
| Fosfomycin | Makes it | Xiromed, LLC. | 70700-268 |
| Ketoconazole | Makes it | Xiromed, LLC. | 70700-160 |
| Lansoprazole | Makes it | Xiromed, LLC. | 70700-262, 70700-263 |
| Omeprazole | Makes it | Golden State Medical Supply, Inc., Xiromed, LLC. | 51407-641, 51407-813, 51407-943 +3 |
| Terbinafine | Makes it | Breckenridge Pharmaceutical, Inc. | 51991-526 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 17, 2025 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Apr 19, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 12, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Jun 27, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 25, 2010 | 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.
Feb 12, 2016 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - No written record of investigation 21 CFR 211.192
Written records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications . - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. - Complete record of all laboratory test data 21 CFR 212.60(g)(3)
Laboratory records did not contain a complete record of all data obtained in the course of each test.
Registered with FDA for: analysis; label; manufacture; pack.