FDA WARNING_LETTER - Ventlab LLC - June 04, 2014

On July 2, 2014, the FDA issued a Warning Letter to Ventlab LLC following an inspection from May 2 to June 4, 2014, which found their Ventlab Manual Resuscitation Bags to be adulterated. The inspection revealed non-conformity with Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: Ventlab failed to fully analyze complaints related to duckbill nonconformities after opening CAPA 13-011 and did not review data to evaluate CAPA effectiveness before closure. The firm's response was inadequate regarding past complaints and future CAPA management. 2. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: 34 of 38 complaint records for stuck duckbill valves lacked required information, hindering thorough investigation. This also led to failure to report Complaint 791, which involved a resuscitator diaphragm failure causing delayed treatment and necessitating medical intervention. The firm's response for past complaints was inadequate, though future plans appeared sufficient. 3. **Failure to control purchased product (21 CFR 820.50(a) and (b))**: Ventlab used patient valves from a supplier that did