# FDA 483 - Allergen Medical - July 07, 2015

Source: https://www.keypedia.com/records/483/allergen-medical/eea4f383-2643-4ebb-a0e1-4517c86e510f

> FDA 483 for Allergen Medical on July 07, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allergen Medical
- Inspection Date: 2015-07-07
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Allergan Medical in Medford, MA, a medical device manufacturer, revealed two significant observations regarding Medical Device Reporting (MDR) requirements. The firm failed to submit MDRs within the required 30-day timeframe for device malfunctions and also failed to submit several MDRs for events that may have caused or contributed to death or serious injury.

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.keypedia.com/records/warning_letter/allergen-medical/d5263a0f-2496-4a55-8a76-fd4b14e544bf)

## Related Officers

- [Investigator](https://www.keypedia.com/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)

Company: https://www.keypedia.com/companies/allergen-medical/79d707cf-620a-48b5-9176-6d266229f497

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