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Medical Devices / Inspections and Audits

Indianapolis Firm Called Out for Complaint Investigations

Nov. 15, 2019

The FDA hit Indianapolis, Indiana devicemaker Lantz Medical with a Form 483 over a failure to properly investigate complaints and other violations.

An agency inspection revealed that nine out of 11 complaints sampled for review required investigations, but the firm lacked adequate procedures and documentation.  

The facility also lacked adequate procedures for quality audits,  device history records, or to control product that does not conform to specifications, the investigator said.

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