Medical Solutions International received a warning letter for several quality system violations, including the use of unapproved and obsolete documents.

The company did not establish document-control procedures, according to the letter. Changes to documents were not reviewed and approved by an individual in the same function or organization that performed the original review.

The firm, which manufactures the BiPro SDS-CB200 Bicarb mixing and distribution systems for dialysis treatment, also was cited for failure to establish and maintain written procedures for:

• Identifying training needs;
• Identifying product throughout all stages of receipt, production, packaging, distribution and installation;
• Changing specifications, processes and procedures;
• Ensuring that mix-ups, damage or other adverse effects to product do not occur during handling;
• Controlling the storage of product in storage areas and stockrooms;
• Ensuring that only devices approved for release are distributed; and
• Ensuring devices will perform as intended after installation.

Medical Solutions President Jack Dillon said the company has responded to the FDA. “It was just a bad paperwork snafu, and we’ve corrected it,” he said.

SOURCE: FDANEWS