International Hospital Products Slammed for Validation

June 17, 2019

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.

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