FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Inadequate Document Control Lands Stand Aid in Hot Water

Feb. 7, 2019
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The FDA cited Stand Aid of Iowa over shoddy document control, device history records and documentation of nonconforming product activities seen at its Sheldon, Iowa facility during an Oct. 22-23, 2018 inspection.

The devicemaker failed to document nonconforming product activities, including investigation, evaluation, reworking, scrapping and part returns, according to the Form 483.

Some of the firm’s device history records for its Econo-Stand 1600 device didn’t document that the devices were manufactured with the correct parts or correct number of parts, the investigator said.

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