FDA WARNING_LETTER - H & H Wholesale Services, Inc. - December 16, 2011

On March 27, 2012, the FDA issued a Warning Letter to H&H Wholesale Services, Inc. following an inspection from October 25 to December 16, 2011. The inspection revealed that the firm's devices, including OneTouch Ultra 50's Glucose Test Strips, One Step Urine Pregnancy Tests Strips, and One Step THC Urine Test Strips, were adulterated and misbranded.

Key violations of the Quality System regulation (21 CFR Part 820) included: 1. Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)). 2. Failure to establish and maintain procedures for purchasing controls, including evaluating contractors and establishing quality requirements for suppliers (21 CFR 820.50). For example, a broker's warehouse used for storing glucose test strips exceeded the maximum temperature of 86°F, reaching over 110°F and 120°F. 3. Failure to establish and maintain procedures for acceptance of incoming product, lacking documentation for acceptance activities for various test strip shipments (21 CFR 820.80(b)). 4. Failure to establish and maintain procedures for Device History Records (DHRs), with no DHRs created for relabeled or repackaged devices, lacking documentation of sticker approval, shipping methods,