Drug factory · FDA FEI 3005439256
Asm Aerosol-Service Ag
Industriestrasse 11, Möhlin, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Nov 8, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2015: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Azelaic Acid | Makes it | LEO Pharma Inc. | 50222-303 |
| Budesonide | Makes it | Oceanside Pharmaceuticals., Salix Pharmaceuticals, Inc. | 68682-658, 65649-651 |
| Minocycline | Makes it | Journey Medical Corporation | 69489-201, 69489-212, 72356-103 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 8, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 23, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 15, 2017 | No problems found | Drug Quality Assurance | — |
| May 8, 2015 | 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.
Jun 23, 2023 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - 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: analysis; label; manufacture; pack.