Drug factory · FDA FEI 3012152381
Saptalis Pharmaceuticals LLC
20 Davids Drive, Hauppauge, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 6, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2018: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 6, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 6, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 9, 2025 | No problems found | Bioresearch Monitoring | — |
| Sep 9, 2025 | No problems found | Bioresearch Monitoring | — |
| Mar 17, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 17, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 28, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 28, 2018 | 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.
Mar 6, 2026 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 appropriate design, of adequate size and suitably located to facilitate operations for its intended use and cleaning and maintenance. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use and cleaning and maintenance.
Registered with FDA for: manufacture.