# FDA WARNING_LETTER - Diasol Inc. - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/diasol-inc/ee24c38e-8a60-4a13-8353-e0585549b183

> FDA WARNING_LETTER for Diasol Inc. on Unknown Date. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Diasol Inc.
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: On September 25, 2017, the FDA issued a Warning Letter to Diasol, Inc., following an inspection from June 6-21, 2017, at their San Fernando, CA facility. The inspection found that Diasol's liquid and powder dialysate concentrate and sodium bicarbonate products, classified as devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The FDA deemed Diasol's July 5, 2017, response to the FDA-483 observations unacceptable.

Key violations included:
1.  **Production Process Control (21 CFR 820.70(a)):** Failure to control water systems (exceeding microbial limits without disinfection), inadequate filtering procedures for "spiked" concentrates, and lack of procedures for external water testing.
2.  **Design History File (DHF) (21 CFR 820.30(j)):** Absence of a complete DHF for Citrisol Acid Concentrate, lacking documentation for design plan, inputs, outputs, verification, validation, risk analysis, and reviews.
3.  **Design Verification (21 CFR 820.30(f)):** Stability studies for Acid Concentrate products were not conducted per approved protocols

## Related Officers

- [Director, Compliance Branch](https://www.keypedia.com/people/kelly-d-sheppard/7a39a905-ae5b-4ec9-a375-4acb25ff6489)
- [Program Division Director](https://www.keypedia.com/people/shari-j-shambaugh/aaea1185-eca8-41f8-bec7-d5d0024b582d)
- [Sarah A. Della Fave](https://www.keypedia.com/people/sarah-a-della-fave/adff89b6-8109-4330-8eaa-6201cbae4827)

Company: https://www.keypedia.com/companies/diasol-inc/7b436359-8d0b-4ff2-8d09-c7e87f41e6b6

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b