FDA Inspection
Brymill CorporationBrymill Corporation – FDA Inspection, Nov 7, 2008
Record Details
This FDA Inspection record concerns Brymill Corporation, with an inspection on November 7, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Brymill Corporation
- Inspection Date
- November 7, 2008
- Product Type
- Devices
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ID · fc991b81-a965-4274-b775-24f04a3d6887
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 546390
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training
- 21 CFR 820.184DHR content
- 21 CFR 820.184(b)Quantity manufactured
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Brymill Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 25, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 12, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Brymill Corporation
- FDA Inspection 1042003 - 2018-02-23
- FDA Inspection 838562 - 2013-06-25
- FDA Inspection 639664 - 2010-01-12
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