FDA Inspection
Arnold Tuber Industries, LLCArnold Tuber Industries, LLC – FDA Inspection, Jun 23, 2017
Record Details
This FDA Inspection record concerns Arnold Tuber Industries, LLC, with an inspection on June 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ecccfe90-24b3-4a48-bd59-da7c1d4acd16
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1016036
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Arnold Tuber Industries, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2025 | NAI | New York District Office | Postmarket Assurance: Medical Devices |
| March 14, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 7, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 4, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 27, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Arnold Tuber Industries, LLC
- FDA Inspection 1261996 - 2025-02-20
- FDA Inspection 1164627 - 2022-03-14
- FDA Inspection 1109606 - 2019-11-07
- FDA Inspection 809059 - 2012-12-04
- FDA Inspection 727140 - 2011-05-27
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