FDA WARNING_LETTER - Diasol Inc - May 28, 2010

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