FDA Inspection
Analytic Biosurgical Solutions (ABISS)Analytic Biosurgical Solutions (ABISS) – FDA Inspection, May 31, 2018
Record Details
This FDA Inspection record concerns Analytic Biosurgical Solutions (ABISS), with an inspection on May 31, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- May 31, 2018
- Product Type
- Medical Devices & Rad Health
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ID · be7807af-b019-46ac-b96d-f51557e57c81
Inspection Facts
- Inspection number
- 1055592
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
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Other FDA inspections of Analytic Biosurgical Solutions (ABISS)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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