Company
United StatesSybaritic, Inc, Bloomington, MN – FDA Inspections
Inspection records and compliance data for Sybaritic, Inc in Bloomington, Minnesota. 11 FDA inspections on record (5 OAI), 1 Form 483, last inspected October 05, 2023.
Company Profile
This profile covers Sybaritic, Inc based in Bloomington, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 5
- VAI
- 1
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected March 18, 2009. Last inspected October 5, 2023.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures2 inspections
- Procedural requirements2 inspections
- Documentation of disposition, justification, signature1 inspection
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 5, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1221747 |
| September 8, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1179596 |
| September 16, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1152434 |
| July 2, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1096300 |
| March 7, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1044931 |
| September 7, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 991196 |
| August 9, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 842801 |
| June 29, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 789805 |
| March 5, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 648102 |
| March 30, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 572634 |
| March 18, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 572930 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sybaritic, Inc
FEI Number
2131125
Address
9220 James Ave S, Bloomington, Minnesota 55431, United States
Country
United States
ID: bb4e425f-cb0e-467d-8115-241abe64be77