FDA WARNING_LETTER - Medical Solutions International, Inc. - March 17, 2008

On March 5-17, 2008, an FDA inspection of Medical Solutions International, Inc. in Merriam, Kansas, revealed that their BiPro SDS-CB200 Bicarb Mixing and Distribution Systems, classified as devices, are adulterated. This is due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: - **Failure to establish and maintain document control (21 CFR 820.40):** No document control procedures, unapproved/obsolete documents in use, and unapproved document changes. - **Failure to establish and maintain written procedures in multiple areas:** - Identifying training needs (21 CFR 820.25(b)). - Identifying product throughout all stages (21 CFR 820.60). - Changes to specifications, processes, and procedures (21 CFR 820.70(b)). - Labeling (21 CFR 820.120). - Preventing mix-ups, damage, or adverse effects during handling (21 CFR 820.140). - Controlling product storage (21 CFR 820.150(a)). - Controlling and distributing finished devices (21 CFR 8