FDA WARNING_LETTER - ThyssenKrupp Access Manufacturing, LLC - November 10, 2011

On March 27, 2012, the FDA issued a Warning Letter to ThyssenKrupp Access Manufacturing, LLC (TKAM) following an inspection from November 8-10, 2011. The inspection found that TKAM, a manufacturer of vertical wheelchair lifts (defined as devices under 21 U.S.C. 321(h)), had adulterated devices under Section 501(h) of the Act, as their manufacturing processes did not conform to the Quality System (QS) Regulation (21 CFR Part 820).

Key violations included: 1. **Failure to investigate complaints (21 CFR 820.198(c)):** TKAM did not investigate several complaints (e.g., leaking cylinder seal, keyswitch coming apart, ball nut failure) and their procedure lacked documentation for investigations or decisions not to investigate. Many External Quality Reports (EQRs) were not closed or lacked sufficient detail. This was a repeat observation from a June 2007 inspection. 2. **Failure to establish CAPA procedures (21 CFR 820.100(a)):** The CAPA procedure lacked requirements for analyzing quality data and verifying/validating corrective actions. No defined action limits for quality problems existed, and no corrective actions were identified in reviewed EQR records. This was also a repeat observation from June