Company
United StatesEastern Cranial Affiliates, LLC, Fairfax, VA – FDA Inspections
Inspection records and compliance data for Eastern Cranial Affiliates, LLC in Fairfax, Virginia. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected June 13, 2024.
Company Profile
This profile covers Eastern Cranial Affiliates, LLC based in Fairfax, Virginia, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 18, 2010. Last inspected June 13, 2024.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Design plans - Lack of or inadequate1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 13, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1242962 |
| February 2, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1039722 |
| October 12, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 749386 |
| April 13, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 719457 |
| June 18, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 667087 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Eastern Cranial Affiliates, LLC
FEI Number
3005021665
Address
10523 Main St, Fairfax, Virginia 22030, United States
Country
United States
ID: 34286952-2212-4ad7-b250-b3b9585ab87d