Company
United StatesHuman Biosciences, Inc., Gaithersburg, MD – FDA Inspections
Inspection records and compliance data for Human Biosciences, Inc. in Gaithersburg, Maryland. 5 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected February 15, 2022.
Company Profile
This profile covers Human Biosciences, Inc. based in Gaithersburg, Maryland, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 1
First inspected October 18, 2011. Last inspected February 15, 2022.
Most cited issue areas
- DHR - not or inadequately maintained2 inspections
- Documentation2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 15, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1162318 |
| June 27, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1017351 |
| July 19, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 839569 |
| January 4, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 810166 |
| October 18, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 748491 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Human Biosciences, Inc.
FEI Number
3008770963
Address
940 Clopper Rd, Gaithersburg, Maryland 20878, United States
Country
United States
ID: 1396dcaa-6c36-4bff-910b-20937317db70