FDA Inspection
Brant-Wald Surgicals IncBrant-Wald Surgicals Inc – FDA Inspection, Apr 8, 2009
Record Details
This FDA Inspection record concerns Brant-Wald Surgicals Inc, with an inspection on April 8, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Brant-Wald Surgicals Inc
- Inspection Date
- April 8, 2009
- Product Type
- Devices
View Company Profile
ID · 977592f8-c7c9-41ad-a4f4-f3c8c6b94180
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 575645
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.70(a)(2)Production monitoring and control
- 21 CFR 820.20Management responsibility
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.86Maintained
- 21 CFR 820.184DHR content
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
Showing 10 of 11 citations.
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Other FDA inspections of Brant-Wald Surgicals Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 11, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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