# FDA WARNING_LETTER - Munroe Regional Medical Centre - September 21, 2009

Source: https://www.keypedia.com/records/warning_letter/munroe-regional-medical-centre/cdf4a5fe-0222-4374-9ad1-9c06d912ac1f

> FDA WARNING_LETTER for Munroe Regional Medical Centre on September 21, 2009. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Munroe Regional Medical Centre
- Inspection Date: 2009-09-21
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On September 14, 15, and 21, 2009, an FDA inspection of Munroe Regional Medical Center, Inc. in Ocala, Florida, revealed the facility, a medical device user facility, was not in conformance with Medical Device Reporting (MDR) regulations (21 CFR Part 803). The EsophyX™ devices used at the facility were deemed misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act due to failure to furnish required information.

Violations included:
1.  **Failure to develop, maintain, and implement adequate written MDR procedures (21 CFR 803.17):** An incident on July 29, 2009, involving a patient suffering a torn esophagus during an EsophyX™ procedure, was determined by Munroe not to be serious or reportable without documented justification. The facility's revised policies lacked provisions for timely identification, communication, and evaluation of reportable events; a standardized review process for reporting criteria; timely transmission of reports; and documentation/recordkeeping of evaluation information.
2.  **Failure to maintain complete MDR event files (21 CFR 803.18(b)(1)(i)):** The July 29, 2009, incident report did not document the deliberations and decision-making processes for determining reportability.
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## Related Officers

- [Director](https://www.keypedia.com/people/timothy-a-ulatowski/23498f67-5e0f-4b28-9039-ad64e2dd5b04)

Company: https://www.keypedia.com/companies/munroe-regional-medical-centre/3f971def-215e-427f-bebc-39c894bb19e8

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