Drug factory · FDA FEI 1521876
North American Science Associates, LLC
6750 Wales Road, Northwood, OH, United States
No problems found at FDA's last inspection, Apr 26, 2024.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2011: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Plazomicin | Tests it | Achaogen, Inc., Cipla Therapeutics Inc., Cipla USA., Inc. | 71045-010, 80735-820, 69097-820 |
| Sebelipase Alfa | Tests it | Alexion Pharmaceuticals Inc. | 25682-007 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 26, 2024 | No problems found | Drug Quality Assurance | — |
| Feb 8, 2017 | No problems found | Drug Quality Assurance | — |
| Apr 30, 2014 | No problems found | Drug Quality Assurance | — |
| Jan 18, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 9, 2011 | 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.
Jan 18, 2013 inspection
- Sterility/pyrogens - test methods written, followed 21 CFR 211.167(a)
Test procedures relative to appropriate laboratory testing for sterility are not followed.
Registered with FDA for: analysis.