GenesiscareFebruary 25, 2020

FDA 483 - Genesiscare - February 25, 2020

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Genesiscare

Record Details

21st Century Oncology, Inc. in Naples, FL, a blood irradiation establishment, received a Form 483 with two observations. The inspection revealed significant issues with recordkeeping for blood and blood component irradiation processes, including undocumented verification steps and recurrent deficiencies in log entries. Additionally, the firm failed to consistently follow its own written standard operating procedures for blood irradiation documentation.

Company: Genesiscare
Inspection Date: February 25, 2020
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
Person: Annette Melendez

Open in Dashboard

ID · 62cc8568-2f31-4766-a7c0-f6c9f4160789