Company
United StatesHand Biomechanics Lab, Inc., Sacramento, CA – FDA Inspections
Inspection records and compliance data for Hand Biomechanics Lab, Inc. in Sacramento, California. 5 FDA inspections on record (1 OAI), 2 Form 483s, last inspected July 12, 2023.
Company Profile
This profile covers Hand Biomechanics Lab, Inc. based in Sacramento, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected January 27, 2010. Last inspected July 12, 2023.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Lack of or inadequate process validation2 inspections
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 12, 2023 | Not classified | Medical Devices & Rad Health | 1214361 |
| April 4, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1049247 |
| July 5, 2017 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1016932 |
| November 20, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 904203 |
| January 27, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 641526 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Hand Biomechanics Lab, Inc.
FEI Number
2919128
Address
77 Scripps Dr Ste 100 101 And 104, Sacramento, California 95825, United States
Country
United States
ID: ba919ab8-25bd-4b14-b98e-6cafe22a1ff8