# FDA WARNING_LETTER - Intelligent Hospital Systems - September 22, 2011

Source: https://www.globalkeysolutions.net/records/warning_letter/intelligent-hospital-systems/99e2f113-9b1f-4bab-902c-ff02c4ac67da

> FDA WARNING_LETTER for Intelligent Hospital Systems on September 22, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Intelligent Hospital Systems
- Inspection Date: 2011-09-22
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Thomas Doherty](https://www.globalkeysolutions.net/people/thomas-doherty/6d02cf96-06c2-4f64-b2c2-e0185d7691cc)
- [President](https://www.globalkeysolutions.net/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.globalkeysolutions.net/companies/intelligent-hospital-systems/6a864e36-9052-4b4e-b9c1-11b4974b7861

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7