FDA WARNING_LETTER - Diasol East, Inc. - March 17, 2017

On July 12, 2017, the FDA issued a Warning Letter to Diasol East, Inc. following an inspection from February 21 to March 17, 2017, at their Watertown, TN facility. The inspection revealed that Diasol East, a manufacturer of liquid and powder dialysate concentrate for hemodialysis, produced adulterated devices under section 501(h) of the Act. The manufacturing processes, facilities, and controls were not in conformity with the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Production Process Control (21 CFR 820.70(a)):** Failure to adequately develop, conduct, control, and monitor production processes. Procedures for Diasol Liquid Acid Concentrate manufacturing were not followed, lacked required testing documentation, referenced processes and equipment from other sites not used in Tennessee, and contained inaccurate mixing times. 2. **Finished Device Acceptance (21 CFR 820.80(d)):** Inadequate procedures for finished device acceptance. The "Final Acceptance Inspection Batch Release Criteria and Testing" procedure lacked specifics on release responsibility and documentation, had inconsistent release criteria for sodium concentration (with 20 instances of out-of-spec results in reviewed DHRs), and did not adequately describe test methods or off-site testing. 3. **Nonconforming Product Control (