483
Fresh Pond Ventures, LLC dba Firefly GlobalFDA 483 - Fresh Pond Ventures, LLC dba Firefly Global - October 06, 2022
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Record Details
An FDA inspection of Fresh Pond Ventures, LLC dba Firefly Global in Belmont, MA, a medical device manufacturer, identified three significant observations. The firm lacked established procedures for device history records, management review, and quality audits. These findings indicate deficiencies in the firm's quality system for medical device manufacturing.
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ID · e4a273fb-e2ba-48d7-8b65-392affa6fb59