Company
United StatesImplant Direct Sybron Manufacturing LLC, Westlake Village, CA – FDA Inspections
Inspection records and compliance data for Implant Direct Sybron Manufacturing LLC in Westlake Village, California. 10 FDA inspections on record (1 OAI), last inspected July 24, 2025.
Company Profile
This profile covers Implant Direct Sybron Manufacturing LLC based in Westlake Village, California, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 1
- VAI
- 1
- NAI
- 7
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 27, 2009. Last inspected July 24, 2025.
Most cited issue areas
- Environmental control Lack of or inadequate procedures1 inspection
- Individual Report of Malfunction1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 24, 2025 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1276700 |
| April 2, 2025 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1266772 |
| May 12, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1141791 |
| December 2, 2019 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1111746 |
| March 27, 2018 | Not classified | Medical Devices & Rad Health | 1060206 |
| April 21, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 923088 |
| April 3, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 872940 |
| February 10, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 768936 |
| August 16, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 739599 |
| January 27, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 562346 |
FDA documents
Form 483s (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Implant Direct Sybron Manufacturing LLC
FEI Number
3001617766
Address
3050 E Hillcrest Dr, Westlake Village, California 91362, United States
Country
United States
ID: 56a57268-60f3-4c99-93ba-98bc06bf4f44