ASHOM HOME FURNISHINGSBusiness Directories,Company Directories

Company Name: Corporate Name:	ASHOM HOME FURNISHINGS
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Company Address:	1945 Dundas St E,MISSISSAUGA,ON,Canada
ZIP Code: Postal Code:	L4X2T8
Telephone Number:	9052387262
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Website:
Email:
USA SIC Code(Standard Industrial Classification Code):	571216
USA SIC Description:	Furniture-Dealers-Retail
Number of Employees:	1 to 4
Sales Amount:	$500,000 to $1 million
Credit History: Credit Report:	Good
Contact Person:	Tom Kalra
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Complaint Files - U. S. Food and Drug Administration
21 CFR 820 198(c) • Any alleged complaint involving possible failure of a device or labeling packaging to meet any of its specifications must be Reviewed, Evaluated, and Investigated
Medical Device Reporting, Complaints, and Corrections Removals . . .
To address test-related complaint handling requirements outlined in 21 CFR 820 198, a laboratory may decide to expand its current complaint handling procedures, which meet CLIA
Mandatory Reporting Requirements: Manufacturers, Importers and Device . . .
The FDA published a final rule on Feb 14, 2014, requiring manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR)
Page 4 | FDA
Under the QS GMP there continues to be no requirement that all complaints be maintained in one file However, firms are now required to have written procedures for processing complaints
Quality System (QS) Regulation Medical Device Current Good . . .
Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820 198) or from general requirements concerning records (21
Medical Device Reporting for Mandatory Reporters - Transcript
21 CFR 820 198 specifically details the requirement for manufacturers to maintain a system for collecting and reviewing complaints about their devices These are considered complaint
Medical Device Reporting | FDA
A standard review process procedure for determining when an event meets the criteria for MDR reporting and ensuring the timely transmission of complete device reports to FDA
Medical Device Reporting for Manufacturers - U. S. Food and Drug . . .
This guidance document describes and explains the Food and Drug Administration’s (FDA, we, us) current regulation that addresses reporting and recordkeeping requirements applicable to
FDA Medical Device Inspections
Management Controls What records can we review in MC? Answer: Read the QSIT Guide, 21 CFR Part 820 regulations and preamble