FDA WARNING_LETTER - Advanced Renal Technologies Inc - April 16, 2014

During an inspection from March 24-31, 2014, and April 16, 2014, the FDA determined that Advanced Renal Technologies Inc., a specification developer of Citrasate (a dialysate for hemodialysis), manufactured adulterated devices. The manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System regulation (21 CFR Part 820).

Violations included: 1. Failure to establish and maintain procedures for purchased products and services (21 CFR 820.50), with inadequate implementation and documentation of the "ART Control of Suppliers Policy." This included lack of documented communication with contract manufacturers (CMs), no documentation of FDA Establishment Inspection Report reviews for CMs, and failure to conduct required inspection visits to CMs. 2. Failure to establish and maintain quality requirements for suppliers, contractors, and consultants (21 CFR 820.50(a)), lacking a procedure defining quality requirements for CMs and documentation of contractor evaluation/selection. 3. Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)). 4. Failure to establish and maintain design control procedures (21 CFR 820.30(a)). 5. Failure to establish quality audit procedures and conduct audits (21 CFR 8