Diasol Inc. – FDA Warning Letter

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