FDA WARNING_LETTER - Intelligent Hospital Systems - September 22, 2011

On September 19-22, 2011, an FDA inspection of Intelligent Hospital Systems in Winnipeg, Canada, revealed that their RIVA pharmaceutical compounding device was adulterated under 21 U.S.C. § 351(h). The firm's manufacturing, packing, storage, or installation methods, facilities, or controls did not conform to the Quality System regulation (21 CFR Part 820).

The Warning Letter cited several violations, including: 1. **Failure to establish and maintain adequate procedures for corrective and preventive action (21 CFR 820.100(a))**: The Corrective and Preventive Action Procedure, QAP0600, lacked definitions for CAPA investigation, identifying actions to prevent recurrence, and verifying/validating effectiveness. The firm's response was inadequate, as the updated procedure still lacked details on identifying recurrence prevention actions, and no evidence of implementation or training was provided. 2. **Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a))**: Procedure FDA0903, used by call center and technical support employees, did not define the timeframe or criteria for determining what constitutes a complaint, documentation requirements, or reference the firm's Complaint Procedure, QAP0500. The adequacy of the firm's response could not be determined due to