Company
United StatesBALT USA, LLC, Irvine, CA – FDA Inspections
Inspection records and compliance data for BALT USA, LLC in Irvine, California. 6 FDA inspections on record, 1 Form 483, last inspected October 28, 2025.
Company Profile
This profile covers BALT USA, LLC based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 22, 2012. Last inspected October 28, 2025.
Most cited issue areas
- Acceptance status1 inspection
- Documentation1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 28, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1291542 |
| June 12, 2025 | Not classified | Medical Devices & Rad Health | 1273490 |
| July 21, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1210642 |
| March 12, 2020 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1120825 |
| February 18, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 958563 |
| May 22, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 793968 |
FDA documents
Form 483s (2)
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Company Information
Name
BALT USA, LLC
FEI Number
3014162263
Address
29 Parker Ste 100, Irvine, California 92618, United States
Country
United States
ID: 6783eb4f-96f7-4c7c-80d9-4447fdb185cc