FDA Inspection
Hand Biomechanics Lab, Inc.Hand Biomechanics Lab, Inc. – FDA Inspection, Jul 5, 2017
Record Details
This FDA Inspection record concerns Hand Biomechanics Lab, Inc., with an inspection on July 5, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 47dac604-9817-45e7-b5c2-f9d4e1406913
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1016932
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 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 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hand Biomechanics Lab, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2023 | Not classified | San Francisco District Office | |
| April 4, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 20, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 27, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hand Biomechanics Lab, Inc.
- FDA Inspection 1214361 - 2023-07-12
- FDA Inspection 1049247 - 2018-04-04
- FDA Inspection 904203 - 2014-11-20
- FDA Inspection 641526 - 2010-01-27
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