Company
United StatesDecimal LLC, Sanford, FL – FDA Inspections
Inspection records and compliance data for Decimal LLC in Sanford, Florida. 6 FDA inspections on record, 1 Form 483, last inspected July 10, 2025.
Company Profile
This profile covers Decimal LLC based in Sanford, Florida, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 18, 2009. Last inspected July 10, 2025.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 10, 2025 | Not classified | Medical Devices & Rad Health | 1276730 |
| November 9, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1193307 |
| February 23, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1042018 |
| May 1, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 924442 |
| June 29, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 788628 |
| June 18, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 591227 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Decimal LLC
FEI Number
3003586672
Address
121 Central Park Pl, Sanford, Florida 32771, United States
Country
United States
ID: d2793ea5-fca4-4db3-8e2c-1d864b726c60