Drug factory · FDA FEI 3013722099
scPharmaceuticals Inc.
25 Mall Road, Suite 203, Burlington, MA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 25, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2024: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Furosemide | Makes it | scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation | 71767-100, 71767-111 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 25, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
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 25, 2024 inspection
- Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Registered with FDA for: label; pack.