International Hospital Products, Inc. – FDA Warning Letter, Mar 19, 2019

On May 29, 2019, the FDA issued a Warning Letter to International Hospital Products, Inc. following an inspection from March 15-19, 2019, at their Littleton, CO facility. The inspection revealed that the firm, a manufacturer of Class II Baker Jejunostomy and intestinal tubes, was not in conformity with the Quality System regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Act.

The FDA identified nine significant violations: 1. **Inadequate Process Validation (21 CFR Part 820.75(a)):** Lack of documented procedures and insufficient validation for sterilization and package sealing processes. Sterilization validation was outdated and incomplete, and packaging validation lacked proper documentation. 2. **Lack of Finished Device Acceptance Procedures (21 CFR Part 820.80(d)):** No documented process or records for visual inspection and sterility confirmation of finished devices. 3. **Insufficient Purchasing Controls (21 CFR Part 820.50):** Absence of procedures for evaluating contract manufacturers and sterilizers, and issues with outdated or unapproved product specifications being used by suppliers. 4. **No Device Master Record (DMR) (21 CFR Part 820.181):** Failure to maintain a comprehensive DMR, leading to inconsistencies in specifications used for