Dive Brief:

• FDA sent a warning letter to Colorado-based International Hospital Products May 29 outlining a series of violations in the sterilization process for the company’s jejunostomy and intestinal tubes used for bowel decompression, the agency disclosed Tuesday.
• FDA also found fault with the company’s procedures for evaluating its suppliers and inspecting finished devices.
• The letter gave International Hospital Products 15 business days to specify in writing the steps it has taken to correct the violations and prevent similar problems from occurring in the future. 

Dive Insight:

International Hospital Products contracts out the assembly, pouch sealing and sterilization of its jejunostomy and intestinal tubes, according to the warning letter. Several issues described in the letter stem from procedures involving the company’s suppliers.

An FDA investigator identified the quality system regulation violations during an inspection of International Hospital Products’ Littleton facilities from March 15-19. In its March 25 response to the investigator’s observations, the company told FDA to expect another response within 90 days. That answer was inadequate, FDA said, because it lacked additional information on corrections or supporting documentation.

Although the company’s products are labeled sterile, FDA said International Hospital Products didn't provide requested documents to demonstrate process validation for sterilization or package sealing to maintain a sterility barrier was performed.

FDA found the company hadn't established procedures for inspecting incoming finished devices. International Hospital Products told FDA it conducted a visual inspection of the devices, but the agency determined the company’s documentation was insufficient and didn't include what possible defects the company looked for during the process, according to the warning letter.

International Hospital Products didn't have procedures in place for evaluating its manufacturing and sterilization suppliers, FDA said. The company had no records to show it reviewed the contract manufacturer it had used since May 2017 or the contract sterilizer in use since before the firm moved from its prior location in 2013, according to the warning letter.

Specifications for several product numbers used by the contract supplier to manufacturer the company’s devices also weren't current, FDA said. 

In all, FDA cited nine violations in the warning letter. The company couldn't provide a required device master record for its jejunostomy and intestinal tubes, and it had not maintained a device history record. Procedures for design changes, complaint handling, quality audits, and control of nonconforming products also hadn't been set up, the warning letter said.

The agency directed International Hospital Products to provide information on how it is ensuring sterilization for current products and those to be distributed in the future. It also requested the company establish procedures to meet regulatory requirements, retain records and provide a timeframe for when corrections can be completed. Failure to correct the violations promptly may result in further regulatory actions including seizure, injunction and monetary penalties, FDA said.