FDA WARNING_LETTER - Respironics California Inc - May 08, 2014

On November 17, 2014, the FDA issued a Warning Letter to Respironics California, Inc. following an inspection from April 14 to May 8, 2014. The inspection revealed that the firm's mechanical ventilators (V60, V200) and services for discontinued ventilators (e.g., Esprit V1000) are misbranded under Section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act.

The primary violations relate to failures in Medical Device Reporting (MDR) under 21 CFR Part 803:

1. **Failure to report device malfunctions within 30 calendar days** (21 CFR 803.50(a)(2)): Several complaints (e.g., PR ID #s: 2777649, 1961008) concerning life-sustaining/life-supporting device malfunctions were not reported or were reported beyond the 30-day timeframe. The firm's initial response was deemed inadequate due to a lack of documentation. A later response, including "Medical Device Determination" (QST3-3412 Rev. A), appeared adequate.

2. **Failure to include all reasonably known information in reports** (21 CFR 803.50(b)(3)): The firm failed to document