International Hospital Products Slammed for Validation
The FDA cited Littleton, Colorado devicemaker International Hospital Products for poor documentation of its validation activities.
The firm was missing a final report for sterilization validation of its Baker Jejunostomy Tube products, which it outsourced to a sterilization supplier. The documentation procedure was not assessed for adequacy since 2003, the agency investigator said, in a Form 483 report.
In addition, the company’s documentation for pouch sealing validation conducted by a contract manufacturer did not include a validation protocol, validation activities, raw data, equipment used and a final report.