FDA WARNING_LETTER - Alber GmbH - May 11, 2017

On September 15, 2017, the FDA issued a Warning Letter to Alber GmbH following an inspection from May 8-11, 2017, in Albstadt, Germany. The inspection found that Alber GmbH, a manufacturer of wheelchair power drive add-ons like the Twion Power Push-Rim Power Drive System, was not in conformity with Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Failure to control design changes (21 CFR 820.30(i)):** Software changes for the Twion smartphone application were not controlled via the Engineering Change Control (ECN) process. Additionally, a design change test (ECN 16-00052) referencing ISO 7176-8:1998 lacked documentation of compliance with the standard. This was a recurring observation. The firm's response was inadequate, lacking completed corrective actions or a retrospective analysis plan. 2. **Failure to establish complaint procedures (21 CFR 820.198(a)):** Seven of twenty-three reviewed Twion complaints lacked investigations or documentation for why an investigation was not conducted. The firm's response was indeterminate, with proposed revisions and analyses lacking evidence of completion