The FDA hit Medco Manufacturing with a Form 483 for numerous violations at its a Spring, Texas facility, including problems with device history and master records.
During an inspection, the agency investigator noted an unmaintained device master record for the firm’s Aspirator IV portable suction pump. Specifically, the record didn’t document elements of the device to ensure each manufactured product met design specifications.
In addition, the product’s device history records were deficient. Test results were not maintained to show acceptance criteria were met and that the device was made in accordance with its master record, the agency said.