Drug factory · FDA FEI 3003011665
Aminolab Ltd.
1 Sapir Pinchas Street, Ness Ziona, Israel
Problems found, fixed voluntarily at FDA's last inspection, Aug 2, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2014: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Omidubicel and Omidubicel Non-Cultured Fraction | Tests it | Gamida Cell Inc. | 73441-800 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 2, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 2, 2014 | 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.
Aug 2, 2022 inspection
- 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.
Registered with FDA for: analysis.