Drug factory · FDA FEI 1313700
F. M. Howell & Company
151 East Fifth Street, Elmira, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 10, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2008: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Toremifene | Packages it | ProStrakan, Inc. | 42747-327 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 10, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 22, 2021 | No problems found | Drug Quality Assurance | — |
| Nov 2, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 2, 2012 | No problems found | Drug Quality Assurance | — |
| Oct 8, 2008 | No problems found | 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.
Oct 10, 2025 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Registered with FDA for: label; pack; relabel; repack.