Process validation failures, documentation lapses and failure to establish corrective and preventive actions were just a few of the quality lapses found during a March 15-19 inspection of International Hospital Products’ Littleton, Colorado facility.
The 11-item Form 483 notes that the firm received and distributed sterilized Jejunostomy tubes, but without documenting sterilization validation following a change in the manufacturing supplier.
The agency found inadequate documentation of pouch sealing validation in that the firm’s contract manufacturer didn’t demonstrate that pouch sealing was performed according to established procedures—including a validation protocol, validation activities, raw data, equipment used and a final report.
The devicemaker also failed to establish procedures for finished device acceptance as well as procedures to ensure that all received products conformed to specifications.
International Hospital Products is the specification developer, manufacturer and distributor of the Baker Jejunostomy tube, but it hadn’t established finished device acceptance steps to ensure that each production run or lot of finished devices met acceptance criteria.
The firm had not established quality system requirements to ensure devices complied with regulatory requirements. The facility lacked a device history record, a device master record, and procedures for design change.
Also missing were specific requirements for sterilization validation process evaluation and monitoring and acceptance testing, the investigator said.
Read the International Hospital Products Form 483 here: www.fdanews.com/06-20-19-intlhospitalprodinc483.pdf.