Three Devicemakers Cited for CAPA, Other Deficiencies

July 14, 2017

Three device manufacturing facilities landed Form 483s from the FDA after inspections turned up numerous problems with their CAPA, complaint, training and MDR procedures.

The FDA issued a Form 483 to Full Range Rehab, citing problems with its CAPA procedures, acceptance activities, record-keeping and complaint handling.

Cirurgica landed a Form 483 from the FDA for inadequate process validation, CAPA procedures, environmental conditions and training. Investigators found numerous manufacturing processes for the firm’s Omiderm device had not been verified and also fell short on several procedures to control environmental conditions.

The FDA hit CarboFix Orthopedics on MDR submissions, anti-contamination efforts and quality audits. Investigators further found that the facility did not perform quality audits at defined intervals.

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