FDA Inspection
BALT USA, LLCBALT USA, LLC – FDA Inspection, Jul 21, 2023
Record Details
This FDA Inspection record concerns BALT USA, LLC, with an inspection on July 21, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f56994fb-9ff1-4f02-9dba-153e6e756596
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210642
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.86Acceptance status
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.86Acceptance status
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Other FDA inspections of BALT USA, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 12, 2025 | Not classified | Los Angeles District Office | |
| March 12, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 18, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 22, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BALT USA, LLC
- FDA Inspection 1291542 - 2025-10-28
- FDA Inspection 1273490 - 2025-06-12
- FDA Inspection 1120825 - 2020-03-12
- FDA Inspection 958563 - 2016-02-18
- FDA Inspection 793968 - 2012-05-22
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