FDA Faults Brit Systems’ CAPAs

December 8, 2017

The FDA issued a Form 483 to Brit Systems in Dallas, Texas following an inspection in late August.

The agency said the company’s CAPA procedures were inadequate as they did not include requirements for verifying or validating a corrective or preventative action.

The agency also cited the facility for failing to have written procedures for managing medical device reportable events and for having a complaint handling procedure that did not evaluate MDR complaints.

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