# FDA 483 - Rochester General Hospital - December 09, 2015

Source: https://www.globalkeysolutions.net/records/483/rochester-general-hospital/7f82132d-3ac5-4c7d-9d7f-284534e670e3

> FDA 483 for Rochester General Hospital on December 09, 2015. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rochester General Hospital
- Inspection Date: 2015-12-09
- Office Name: New York District Office
- Summary: An FDA Form 483 was issued to Rochester General Hospital following an inspection conducted from December 7 to December 9, 2015. The inspection identified a significant issue concerning the hospital's Medical Device Reporting (MDR) procedures. Specifically, the FDA observed that Rochester General Hospital had not fully implemented its written MDR procedures. This deficiency manifested in incomplete documentation within MDR event files, lacking full records of deliberations and the decision-making process required by their MDR Decision pathway. The report highlighted instances where patient identifiers were associated with incomplete documentation. Furthermore, the hospital could not demonstrate that its procedures effectively ensured the timely and efficient identification, communication, and evaluation of events that might be subject to MDR requirements, citing several incident reports as examples. These observations indicate a potential gap in the hospital's ability to properly track and report adverse events related to medical devices, which is critical for patient safety and regulatory compliance. The regulatory framework for such inspections falls under the Federal Food, Drug, and Cosmetic Act. In response to the observation, Rochester General Hospital committed to correcting the identified issue. This FDA 483 serves as a formal notice of objectionable conditions, prompting the facility to undertake corrective actions to ensure full compliance with regulatory standards for medical device reporting.

Company: https://www.globalkeysolutions.net/companies/rochester-general-hospital/a42617ee-9a6e-456b-8988-1ed39dd501cb

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d