Company
United StatesWhitehall/Div of Acorn Engineering Co, City Of Industry, CA – FDA Inspections
Inspection records and compliance data for Whitehall/Div of Acorn Engineering Co in City Of Industry, California. 2 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected February 14, 2018.
Company Profile
This profile covers Whitehall/Div of Acorn Engineering Co based in City Of Industry, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 1
First inspected March 23, 2017. Last inspected February 14, 2018.
Most cited issue areas
- Design history file2 inspections
- Individual Report of Malfunction2 inspections
- Lack of or inadequate process validation2 inspections
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 14, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1041314 |
| March 23, 2017 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1006245 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Whitehall/Div of Acorn Engineering Co
FEI Number
1000150265
Address
15125 Proctor Ave, City Of Industry, California 91746, United States
Country
United States
ID: 6fa35af0-15bf-4401-bb94-74f22bf4fe5c