FDA Inspection
Sybaritic, IncSybaritic, Inc – FDA Inspection, Mar 18, 2009
Record Details
This FDA Inspection record concerns Sybaritic, Inc, with an inspection on March 18, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sybaritic, Inc
- Inspection Date
- March 18, 2009
- Product Type
- Devices
View Company Profile
ID · 81c742c4-5227-446e-9c95-88797464361a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 572930
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(b)Training
- 21 CFR 820.20Management responsibility
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.90(b)(1)Documentation of disposition, justification, signature
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sybaritic, Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 8, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 16, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 2, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 7, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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 1044931 - 2018-03-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.