FDA Inspection
Dorel Juvenile Group, Inc.Dorel Juvenile Group, Inc. – FDA Inspection, Jul 1, 2011
Record Details
This FDA Inspection record concerns Dorel Juvenile Group, Inc., with an inspection on July 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dorel Juvenile Group, Inc.
- Inspection Date
- July 1, 2011
- Product Type
- Devices
View Company Profile
ID · 795e67f1-8a0f-4939-a1a6-17e36ac5f81c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 733498
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.30(j)Design history file
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Other FDA inspections of Dorel Juvenile Group, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Dorel Juvenile Group, Inc.
- FDA Inspection 892021 - 2014-08-20
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