FDA WARNING_LETTER - Diasol Inc - June 15, 2017

An FDA inspection of Diasol Inc.'s Phillipsburg, NJ facility from May 8 to June 15, 2017, revealed that the firm's manufactured and repacked dialysis concentrates (Dryasol, CitriSol, Diasol Acid Concentrates, Sodium Bicarbonate) are adulterated devices under 21 U.S.C. § 351(h) 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 procedures for finished device acceptance and documentation (21 CFR 820.80(d)&(e)), leading to product shipment before final inspection. The firm also failed to establish and implement procedures for controlling nonconforming product (21 CFR 820.90), resulting in out-of-specification products being released without proper documentation or rework. Additionally, Diasol Inc. failed to validate critical processes like mixing times and cleaning activities (21 CFR 820.75(a)), ensure suitable building design (21 CFR 820.70(f)) with issues like pest ingress and insulation problems, adequately control nonconforming materials by segregating them (21 CFR 820.90), and maintain document control procedures (21 CFR 820.40(a)) as essential documents were not available at required locations. The firm's responses to several observations were deemed inadequate. Prompt corrective actions are required within fifteen working days, with a detailed plan and timeline. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments.