Company
United StatesSwiss American CDMO, LLC, Carrollton, TX – FDA Inspections
Inspection records and compliance data for Swiss American CDMO, LLC in Carrollton, Texas. 9 FDA inspections on record, 2 Form 483s, last inspected December 16, 2024.
Company Profile
This profile covers Swiss American CDMO, LLC based in Carrollton, Texas, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 2
- NAI
- 7
- Form 483s
- 2
- Warning letters
- 0
First inspected July 27, 2009. Last inspected December 16, 2024.
Most cited issue areas
- Complaint Handling Procedure1 inspection
- GMP Training Frequency1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 16, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1251710 |
| December 19, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1193281 |
| March 31, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1165937 |
| December 12, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1114623 |
| September 28, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1067042 |
| June 4, 2015 | NAI | Human Drugs · Drug Quality Assurance | 928487 |
| March 1, 2011 | NAI | Human Drugs · Drug Quality Assurance | 712969 |
| June 11, 2010 | NAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 667023 |
| July 27, 2009 | NAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 599251 |
FDA documents
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Swiss American CDMO, LLC
FEI Number
3001451826
Address
2055 Luna Rd Ste 126, Carrollton, Texas 75006, United States
Country
United States
ID: a4a811fc-a442-480b-a003-b66ee374d059