FDA WARNING_LETTER - Anybattery, Inc. - November 17, 2014

During an FDA inspection from October 21 to November 17, 2014, Anybattery, Inc., a manufacturer of replacement medical device batteries, was found to be in violation of the Federal Food, Drug, and Cosmetic Act. The firm's devices were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulations (21 CFR Part 820).

Key violations included: 1. Failure to establish procedures for corrective and preventive action (21 CFR 820.100(a)). 2. Failure to establish procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)), with specific instances of un-evaluated returned goods authorizations (RGAs) and missing records. 3. Failure to establish design control procedures (21 CFR 820.30(a)), lacking specifications and documentation for design activities. 4. Failure to establish procedures for purchasing controls (21 CFR 820.50), including supplier evaluation. 5. Failure to establish procedures for finished device acceptance (21 CFR 820.80(d)), with undocumented final test results. 6. Failure to establish procedures for acceptance of incoming product (2