FDA Inspection
Generic Medical Devices, Inc.FDA Inspection 780253 - Generic Medical Devices, Inc. - April 25, 2012
Record Details
This FDA Inspection record concerns Generic Medical Devices, Inc., with an inspection on April 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 25, 2012
- Product Type
- Devices
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ID · c3e74b81-c373-415f-adb9-ec755bff6848
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 780253
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Generic Medical Devices, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2010 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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