Drug factory · FDA FEI 3005187155
SwissCo Services AG
Bahnhofstrasse 14, Sisseln, Switzerland
No problems found at FDA's last inspection, Sep 7, 2023.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2011: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Alendronic Acid | Makes it | ASCEND Therapeutics U.S., LLC, Mission Pharmacal Company, Radius Health, Inc. | 17139-400, 0178-0101, 70539-400 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 7, 2023 | No problems found | Drug Quality Assurance | — |
| Sep 14, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Dec 19, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 18, 2013 | No problems found | Drug Quality Assurance | — |
| Jul 8, 2011 | 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.
Sep 14, 2018 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not documented at the time of performance. - Protective Apparel Not Worn 21 CFR 211.28(a)
Protective apparel is not worn as necessary to protect drug products from contamination. - Cleaning SOPs/schedules 21 CFR 211.67(b)(2)
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.
Registered with FDA for: manufacture.