# FDA WARNING_LETTER - Ventlab LLC - June 04, 2014

Source: https://www.keypedia.com/records/warning_letter/ventlab-llc/e7366a77-fada-4183-874d-9f15153a01b1

> FDA WARNING_LETTER for Ventlab LLC on June 04, 2014. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Ventlab LLC
- Inspection Date: 2014-06-04
- Product Type: Devices
- Office Name: Detroit District Office
- Summary: 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

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/art-o-czabaniuk/37f1e249-9ee6-4275-9c28-391d93659b85)

Company: https://www.keypedia.com/companies/ventlab-llc/34128b6b-171d-4d5e-bc2b-ebbb6dfbb290

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03