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# QS Violations at LAR Manufacturing
- URL: https://www.fdaweb.com/qs-violations-at-lar-manufacturing/
- Published: 2016-01-26T12:00:00.000Z
- Updated: 2026-09-15T02:30:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134556

> An 8/31-9/1/15 FDA inspection at LAR MFG, Port Richey, FL, found Quality System Regulation violations in the firm’s manufacturing of ceramic dental brackets, according to a just-released 12/9/15 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm482453.htm?ref=fdaweb.com) from the agency’s Florida District Office. Specific violations noted on an FDA-483 included:  
> failing to validate with a high degree of assurance and approve according to established procedures a manufacturing process that cannot be fully verified by subsequent inspection and testing, to ensure that the process will continue to meet specifications:failing to establish procedures for corrective and preventive action;failing to establish procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained;failing to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities;failing to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and regulations;failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;failing to establish a procedure for quality audits, and to conduct and document quality audits; andfailing to establish quality system procedures and instructions.  
>  
> The letter says that the firm’s 10/5/15 response was inadequate because it failed to outline specific steps it will take for each inspection observation to establish and follow written procedures and policies to conform with FDA regulations.  
>  
> The company was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.