Drug factory · FDA FEI 2027219
ALS Group USA, Corp.
3904 Del Amo Blvd, Torrance, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 5, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2010: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Motixafortide | Tests it | BioLineRx USA Inc, Gamida Cell Inc. | 82737-073, 73441-062 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 5, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 16, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 18, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 1, 2012 | No problems found | Drug Quality Assurance | — |
| Jan 28, 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.
Jun 5, 2023 inspection
- Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of adequate size to facilitate operations for its intended use.
Feb 16, 2018 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Registered with FDA for: analysis.