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FDA Inspection
•Sybaritic, Inc•March 7, 2018

Sybaritic, Inc – FDA Inspection, Mar 7, 2018

Record Details

This FDA Inspection record concerns Sybaritic, Inc, with an inspection on March 7, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company
Sybaritic, Inc
Inspection Date
March 7, 2018
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Kyle J. Mccracken (FDA Associated Person)
View Company Profile

ID · def610b6-5f3d-4a46-be78-03e6fd316ec7

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1044931
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. Procedural requirements

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Sybaritic, Inc

10
DateClassificationOfficeProject area
October 5, 2023NAICenter for Devices and Radiological HealthCompliance: Devices
September 8, 2022NAICenter for Devices and Radiological HealthCompliance: Devices
September 16, 2021NAICenter for Devices and Radiological HealthCompliance: Devices
July 2, 2019NAICenter for Devices and Radiological HealthCompliance: Devices
September 7, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
View all 10 other inspections on the company page
Other documents for Sybaritic, Inc
  • FDA Inspection 1221747 - 2023-10-05
  • FDA Inspection 1179596 - 2022-09-08
  • FDA Inspection 1152434 - 2021-09-16
  • FDA Inspection 1096300 - 2019-07-02
  • FDA Inspection 991196 - 2016-09-07

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