Drug factory · FDA FEI 3011596846
Surmasis Pharmaceutical, LLC
4020 Gannett Avenue, Des Moines, IA, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 1, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2018: 0 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Scopolamine | Makes it | Ingenus Pharmaceuticals, LLC | 50742-505 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 1, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Mar 19, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 1, 2018 | Serious problems, FDA action | 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.
Aug 1, 2025 inspection
- No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Management review - defined interval, sufficient frequency 21 CFR 820.20(c)
Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals. - Quality plan 21 CFR 820.20(d)
A quality plan has not been established.
Registered with FDA for: manufacture.