RX Air Industries LLC. – FDA Warning Letter, May 19, 2011

On May 17-19, 2011, an FDA inspection of Rx Air Industries, LLC, revealed that their RX3000 air purifiers, intended for medical facility use, are adulterated 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 C.F.R. Part 820).

Key violations include: 1. Failure to validate the "in-house" test method for HEPA filter efficiency (21 C.F.R. § 820.75(a)). The firm's proposed validation plan was inadequate, lacking independent test results, specified lot sizes, and statistically valid sampling. 2. Failure to establish and maintain procedures for finished device acceptance, specifically for filter efficiency testing (21 C.F.R. § 820.80(d)). The new procedure did not require recording test results or explain efficiency calculation. 3. Failure to establish and maintain process control procedures (21 C.F.R. § 820.70(a)). The "Travel Card" procedure did not document adhesive curing time, though the firm stated this was updated. 4. Failure to establish and maintain procedures for nonconforming product control (21 C.