FDA WARNING_LETTER - Amplivox Ltd - December 15, 2011

This FDA Warning Letter, dated May 2, 2012, was issued to Amplivox Limited following an inspection from December 12-15, 2011, which determined the firm manufactures adulterated tympanometers and audiometers. The devices are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

The letter details ten violations, citing inadequate procedures and documentation. Key deficiencies include: 1. Failure to establish and maintain adequate procedures for design change validation/verification (21 CFR 820.30(i)), exemplified by an unvalidated change to the Otowave 102. 2. Failure to establish and maintain adequate procedures for design validation, including risk analysis (21 CFR 820.30(g)), and design verification (21 CFR 820.30(f)). 3. Failure to establish and maintain adequate procedures for defining and documenting design output for evaluation against input requirements (21 CFR 820.30(d)). 4. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints, including determining reportability to FDA (21 CFR 820.198(a)(3)).