FDA Inspection
Decimal LLCDecimal LLC – FDA Inspection, Feb 23, 2018
Record Details
This FDA Inspection record concerns Decimal LLC, with an inspection on February 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · f5d5ce75-66b8-4233-93c7-9fd6d63cd10d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042018
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Decimal LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2025 | Not classified | Florida District Office | |
| November 9, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 1, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 29, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 18, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Decimal LLC
- FDA Inspection 1276730 - 2025-07-10
- FDA Inspection 1193307 - 2022-11-09
- FDA Inspection 924442 - 2015-05-01
- FDA Inspection 788628 - 2012-06-29
- FDA Inspection 591227 - 2009-06-18
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