FDA Inspection
Swiss American CDMO, LLCSwiss American CDMO, LLC – FDA Inspection, Dec 16, 2024
Record Details
This FDA Inspection record concerns Swiss American CDMO, LLC, with an inspection on December 16, 2024, issued by the Dallas District Office, covering medical devices & rad health.
- Company
- Swiss American CDMO, LLC
- Inspection Date
- December 16, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · e81dbe59-5686-43e0-8b5f-56739ff69217
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1251710
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Swiss American CDMO, LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 31, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 12, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 4, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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