FDA Inspection
Medical Accessories, Inc.Medical Accessories, Inc. – FDA Inspection, Apr 30, 2009
Record Details
This FDA Inspection record concerns Medical Accessories, Inc., with an inspection on April 30, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medical Accessories, Inc.
- Inspection Date
- April 30, 2009
- Product Type
- Devices
View Company Profile
ID · deff8421-eed6-443e-a51d-7cc35e6b51ff
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 579641
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(c)Documentation
- 21 CFR 820.198(a)General
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.181(c)DMR QA procedures and specifications
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medical Accessories, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medical Accessories, Inc.
- FDA Inspection 659812 - 2010-04-29
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