FDA Inspection
Whitehall/Div of Acorn Engineering CoWhitehall/Div of Acorn Engineering Co – FDA Inspection, Mar 23, 2017
Record Details
This FDA Inspection record concerns Whitehall/Div of Acorn Engineering Co, with an inspection on March 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Donna L. Besone (Issuing Officer)
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ID · 8506dca1-feba-4492-a86e-b585176f7424
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1006245
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of Whitehall/Div of Acorn Engineering Co
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2018 | Not classified | Los Angeles District Office | Compliance: Devices |
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