Labverity
Facility profile

Swiss-American CDMO, LLC

Drug product manufacturing · Carrollton, TX

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

Manufacture
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Dec 16, 2024 · FDA documented observations for voluntary correction.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

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Shows

Registration status and a latest matched voluntary action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history16 inspection records

FDA inspection history

16 records, Jul 2009 – Dec 2024 · 11 NAI · 5 VAI · 0 OAI

DateClassProject areaCitationsFY
Dec 16, 2024VAICompliance: DevicesYes2025
Dec 16, 2024NAIPostmarket Assurance: DevicesYes2025
Dec 19, 2022VAICompliance: DevicesYes2023
Dec 19, 2022NAIPostmarket Assurance: DevicesYes2023
Mar 31, 2022VAIDrug Quality AssuranceYes2022
Dec 12, 2019NAIDrug Quality Assurance2020
Sep 28, 2018NAIPostmarket Assurance: DevicesYes2018
Sep 28, 2018VAICompliance: DevicesYes2018
Jun 4, 2015NAIDrug Quality Assurance2015
Mar 1, 2011NAIDrug Quality Assurance2011
Jun 11, 2010NAIPostmarket Assurance: Devices2010
Jun 11, 2010NAICompliance: Devices2010
Jun 11, 2010NAIDrug Quality Assurance2010
Jul 27, 2009VAIDrug Quality Assurance2009
Jul 27, 2009NAICompliance: Devices2009
Jul 27, 2009NAIPostmarket Assurance: Devices2009

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

No warning letter, injunction, or seizure is matched in the current data set.

Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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