Drug factory · FDA FEI 3006684386
LabAnalysis Life Science srl
Via Europa 5, Casanova Lonati (PV), Italy
Problems found, fixed voluntarily at FDA's last inspection, Jun 20, 2024.
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 2013: 1 with no problems, 4 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 20, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 27, 2023 | Serious problems, FDA action | Bioresearch Monitoring | — |
| Nov 15, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 17, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 15, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Sep 13, 2013 | 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.
Oct 15, 2015 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed and documented at the time of performance. - Lab controls established, including changes 21 CFR 211.160(a)
The establishment of test procedures and laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit. - 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 components and drug products conform to appropriate standards of identity, strength, quality and purity. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
Registered with FDA for: analysis.