FDA Inspection
Chalgren Enterprises, Inc.Chalgren Enterprises, Inc. – FDA Inspection, Jun 25, 2010
Record Details
This FDA Inspection record concerns Chalgren Enterprises, Inc., with an inspection on June 25, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Chalgren Enterprises, Inc.
- Inspection Date
- June 25, 2010
- Product Type
- Devices
View Company Profile
ID · 7bd7e0d0-d93a-4de0-b8c1-54c8a7b275eb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 669414
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40(b)Document changes, review and approval, communication
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.70(a)Production processes
- 21 CFR 806.20(a)Records not kept
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Chalgren Enterprises, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 28, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 21, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Chalgren Enterprises, Inc.
- FDA Inspection 940407 - 2015-09-03
- FDA Inspection 775186 - 2012-03-28
- FDA Inspection 673672 - 2010-07-21
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