Quality Electrodynamics warned Over CAPA, Complaint Handling
The FDA handed Quality Electrodynamics a warning letter for poor complaint handling, CAPA and validation practices, including failure to adequately validate suppliers.
The April 10 letter says that MRI body coils returned for repairs aren’t properly evaluated to see if they meet the criteria for complaints. A database search of complaints received during the past two years revealed 10 reports of burns and 28 reports of heat that weren’t documented, evaluated or investigated as complaints.
Although the Mayfield Village, Ohio, company has added additional key words to generate complaints from the repair database, its procedure doesn’t require a retrospective review of repairs to determine which stem from complaints and should be evaluated or investigated, the FDA says.
The letter also cites CAPA procedures — specifically the company’s engineering change orders for designs of printed circuit boards.
According to the investigator, the validation of the surface mount technology process completed in January 2014 identified design issues related to the parts for the circuit boards which are components of the MRI coils. Despite updating its CAPA procedures, the system doesn’t address whether a corrective action will be taken for circuit board issues identified during the SMT validation.
The FDA also dinged the company for failing to implement quality requirements for suppliers — specifically, to validate that suppliers properly use processes such as oxide coating used in manufacture of circuit boards and electrical assemblies.
Quality Electrodynamics says it has updated its procedures and that suppliers whose processes require validation have been added to its audit schedule. The company takes the observations in the warning letter seriously, President and CEO Hiroyuki Fujita said.
The warning letter followed a Feb. 10 to March 9 inspection.
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