# FDA 483 - Fresh Pond Ventures, LLC dba Firefly Global - October 06, 2022

Source: https://www.keypedia.com/records/483/fresh-pond-ventures-llc-dba-firefly-global/e4a273fb-e2ba-48d7-8b65-392affa6fb59

> FDA 483 for Fresh Pond Ventures, LLC dba Firefly Global on October 06, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresh Pond Ventures, LLC dba Firefly Global
- Inspection Date: 2022-10-06
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/fresh-pond-ventures-llc-dba-firefly-global/a8dcc6e8-ed3a-4584-8955-0b3d62e58472

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94