FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Device Contract Manufacturer Hit for CAPA Records

March 11, 2019
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The FDA cited IPAX after an Oct. 3-11, 2018 inspection revealed missing documentation for two CAPA records at its Englewood, Colorado facility.

The inspector found that the firm’s written CAPA procedures were inadequate. Two of the eleven records reviewed lacked documentation for approved extension requests for investigations exceeding the required timeframe.

The agency also flagged inadequate procedures for rework of nonconforming product. Two of the 13 nonconformance records reviewed did not include re-inspection activities.

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