FDA Inspection
Hand Biomechanics Lab, Inc.Hand Biomechanics Lab, Inc. – FDA Inspection, Apr 4, 2018
Record Details
This FDA Inspection record concerns Hand Biomechanics Lab, Inc., with an inspection on April 4, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Seema S. Singh (Issuing Officer)
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ID · 5f723800-56e7-4836-9c68-d417349197f9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049247
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Hand Biomechanics Lab, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2023 | Not classified | San Francisco District Office | |
| July 5, 2017 | OAI | 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 1016932 - 2017-07-05
- FDA Inspection 904203 - 2014-11-20
- FDA Inspection 641526 - 2010-01-27
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