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# QS Violations at International Hospital Products
- URL: https://www.fdaweb.com/qs-violations-at-international-hospital-products/
- Published: 2019-06-25T12:00:00.000Z
- Updated: 2026-09-15T01:34:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144420

A 3/15-3/19 FDA inspection at International Hospital Products, Littleton, CO, found Quality System Regulation violations in the firm’s work as a manufacturer (specification developer) of Class 2 Baker Jejunostomy and intestinal tubes used for bowel decompression. A 5/29 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/international-hospital-products-inc-579332-05292019?ref=fdaweb.com) says specific violations were: 

- failing to adequately document and approve process validation activities and results;
- failing to establish procedures for finished device acceptance;
- failing to establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
- failing to maintain a device master record;
- failing to establish procedures for design changes;
- failing to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to maintain a device history record;
- failing to establish procedures to control product that does not conform to specified requirements; and
- failing to establish procedures for quality audits.

International was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation for each step and a timetable for completion.