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FDAnews Device Daily Bulletin

Kentucky Manufacturer Slammed for Weak Quality System

Sept. 16, 2019

Louisville devicemaker Induction Therapies’ lax quality system netted the skincare therapy manufacturer a Form 483 during an FDA inspection.

The agency cited the firm for missing or unimplemented quality system procedures, including management review and quality audit procedures that were not developed.

Procedures for CAPAs, complaint handling, acceptance activity and purchasing control had been developed but were not implemented, the investigator said.

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