FDA Inspection
Implant Direct Sybron Manufacturing LLCImplant Direct Sybron Manufacturing LLC – FDA Inspection, Dec 2, 2019
Record Details
This FDA Inspection record concerns Implant Direct Sybron Manufacturing LLC, with an inspection on December 2, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 2, 2019
- Product Type
- Devices
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ID · 10676b52-ebf1-41ee-8179-cad3c1e6a0f0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1111746
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Implant Direct Sybron Manufacturing LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 2, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 12, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 27, 2018 | Not classified | Los Angeles District Office | |
| April 21, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Implant Direct Sybron Manufacturing LLC
- FDA Inspection 1276700 - 2025-07-24
- FDA Inspection 1266772 - 2025-04-02
- FDA Inspection 1141791 - 2021-05-12
- FDA Inspection 1060206 - 2018-03-27
- FDA Inspection 923088 - 2015-04-21
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