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

Source: https://www.keypedia.com/records/warning_letter/medical-solutions-international-inc/69a570a5-e6dd-4da5-b276-98713a77a5de

> FDA WARNING_LETTER for Medical Solutions International, Inc. on March 17, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Medical Solutions International, Inc.
- Inspection Date: 2008-03-17
- Product Type: Devices
- Office Name: Kansas City District Office
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/john-w-thorsky/7a765cf2-aafc-48f7-98f5-172795a7d0d8)

Company: https://www.keypedia.com/companies/medical-solutions-international-inc/2e13aa05-20d4-40e6-8269-9fb3d8a92c36

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79