FDA Inspection
Banister Tool, IncBanister Tool, Inc – FDA Inspection, Jun 12, 2014
Record Details
This FDA Inspection record concerns Banister Tool, Inc, with an inspection on June 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Banister Tool, Inc
- Inspection Date
- June 12, 2014
- Product Type
- Devices
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ID · d30af210-4f0c-42a1-b349-7c86515a52f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 885273
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Banister Tool, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 7, 2017 | Not classified | Dallas District Office |
Other documents for Banister Tool, Inc
- FDA Inspection 1280218 - 2025-08-21
- FDA Inspection 1030225 - 2017-09-07
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