# FDA WARNING_LETTER - Diasol Inc - May 28, 2010

Source: https://www.keypedia.com/records/warning_letter/diasol-inc/4b11c140-6b32-4b6d-8f64-1ff471a38a34

> FDA WARNING_LETTER for Diasol Inc on May 28, 2010. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Diasol Inc
- Inspection Date: 2010-05-28
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: On August 9, 2010, the FDA issued a Warning Letter to Diasol, Inc. following inspections at their San Fernando, CA (May 19-28, 2010) and Phoenix, AZ (January 1-February 3, 2010) manufacturing sites. The inspections revealed that Diasol, Inc. manufactures liquid and dry hemodialysis concentrates, classified as adulterated devices under section 501(h) of the Act, due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
1.  Failure to validate processes where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), specifically incomplete cleaning validation for liquid dialysis concentrate containers.
2.  Failure to establish and maintain acceptance procedures for in-process products (21 CFR 820.80(c)), observed in water testing procedures.
3.  Failure to document all Corrective and Preventative Action (CAPA) activities and results (21 CFR 820.100), as a CAPA log was not maintained.
4.  Failure to investigate nonconformities to determine the cause (21 CFR 820.100(a)(2)), specifically an uninvest

## Related Officers

- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)
- [Marco S. Esteves](https://www.keypedia.com/people/marco-s-esteves/bfc57711-e37c-4ce1-9c69-a7c0ea21451c)

Company: https://www.keypedia.com/companies/diasol-inc/889a3291-2cd9-4848-b313-928e77a9c1f3

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