Drug factory · FDA FEI 3000203007
Element Materials Technology Pharma US LLC
9240 Santa Fe Springs Rd., Santa Fe Springs, CA, United States
No problems found at FDA's last inspection, Mar 28, 2025.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2009: 5 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lanthanum Cation (3+) | Tests it | Prasco Laboratories, Takeda Pharmaceuticals America, Inc. | 66993-422, 66993-423, 66993-424 +5 |
| Motixafortide | Tests it | BioLineRx USA Inc, Gamida Cell Inc. | 82737-073, 73441-062 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 28, 2025 | No problems found | Drug Quality Assurance | — |
| May 3, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Aug 1, 2018 | No problems found | Drug Quality Assurance | — |
| Mar 25, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 29, 2013 | No problems found | Drug Quality Assurance | — |
| Dec 1, 2010 | No problems found | Drug Quality Assurance | — |
| Jun 11, 2010 | No problems found | Drug Quality Assurance | — |
| Jun 15, 2009 | 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.
May 3, 2019 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established standards, test procedures and laboratory control mechanisms are not followed and documented at the time of performance. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices.
Mar 25, 2016 inspection
- 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 drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
Registered with FDA for: analysis.