Brymill Corporation – FDA Inspection, Jun 25, 2013

Record Details

This FDA Inspection record concerns Brymill Corporation, with an inspection on June 25, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company: Brymill Corporation
Inspection Date: June 25, 2013
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · b3b4f119-63fa-4e13-80a8-5881468e4252

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 838562
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.80(b)Incoming acceptance records, documentation
21 CFR 820.184DHR - not or inadequately maintained
21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.25(b)Training records
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 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.120Lack of or inadequate procedures for labeling
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ

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Other FDA inspections of Brymill Corporation

Date	Classification	Office	Project area
February 23, 2018	OAI	Center for Devices and Radiological Health	Compliance: Devices
January 12, 2010	VAI	Center for Devices and Radiological Health	Compliance: Devices
November 7, 2008	OAI	Center for Devices and Radiological Health	Compliance: Devices