# FDA 483 - Allstar Marketing Group Llc - March 21, 2022

Source: https://www.globalkeysolutions.net/records/483/allstar-marketing-group-llc/8d27b5b3-18e2-41d2-aa85-5bf08dd7177c

> FDA 483 for Allstar Marketing Group Llc on March 21, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allstar Marketing Group Llc
- Inspection Date: 2022-03-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Allstar Marketing Group Llc, a medical device manufacturer in Hawthorne, NY, was inspected by the FDA. The inspection revealed a significant compliance issue regarding the firm's failure to develop written Medical Device Reporting (MDR) procedures. Specifically, the company lacked electronic MDR procedures and had not established an Electronic Submissions Gateway (ESG) account to handle serious injury and death incidents.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.globalkeysolutions.net/companies/allstar-marketing-group-llc/8ece6112-3afa-45b6-8ef5-8dd8348460fe

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961