Mueller Water Conditioning, Inc – FDA Warning Letter, Oct 29, 2009

On September 30, 2009, an FDA inspection of Mueller Water Conditioning, Inc. revealed that the firm's regenerated mixed-bed deionization (DI) and carbon tanks, used for hemodialysis, are adulterated. The manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System (QS) regulations (21 C.F.R. Part 820).

Key violations include: 1. Failure to establish and maintain adequate process controls and to review/approve documents prior to implementation (21 C.F.R. § 820.70(a), § 820.40(a)). The firm lacked written manufacturing procedures for DI resin and carbon tanks, using unrevised procedures from another manufacturer despite different specifications and equipment. 2. Failure to establish and maintain adequate procedures for finished device acceptance and to document results (21 C.F.R. §§ 820.80(d), (e)). No written procedures existed for testing and accepting/rejecting new carbon resins or regenerated DI resins, nor for documenting acceptance results. Verbal specifications for resistivity and rinsing were not documented. 3. Failure to establish and maintain procedures to control labeling activities (21 C.F.R. § 820.120). Written procedures for identifying, printing, applying, and inspecting labels were absent, and labeling