FDA Inspection
SurGenTec, LLCSurGenTec, LLC – FDA Inspection, Apr 18, 2019
Record Details
This FDA Inspection record concerns SurGenTec, LLC, with an inspection on April 18, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b3556f6f-c5c7-4fbb-bec0-7625d7822496
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086833
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
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Other FDA inspections of SurGenTec, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 14, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| October 11, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for SurGenTec, LLC
- FDA Inspection 1194136 - 2022-12-14
- FDA Inspection 1192878 - 2022-12-14
- FDA Inspection 1069659 - 2018-10-11
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