FDA Inspection
Whitehall/Div of Acorn Engineering CoWhitehall/Div of Acorn Engineering Co – FDA Inspection, Feb 14, 2018
Record Details
This FDA Inspection record concerns Whitehall/Div of Acorn Engineering Co, with an inspection on February 14, 2018, issued by the Los Angeles District Office, covering medical devices & rad health.
- Inspection Date
- February 14, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · e7384a33-6615-464f-9891-023671b152ed
Inspection Facts
- Inspection number
- 1041314
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Whitehall/Div of Acorn Engineering Co
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2017 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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