# FDA 483 - Active Medical Inc - January 23, 2020

Source: https://www.keypedia.com/records/483/active-medical-inc/cdc7befd-1031-4b57-9d7b-5d5d7e9d5d20

> FDA 483 for Active Medical Inc on January 23, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Active Medical Inc
- Inspection Date: 2020-01-23
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Active Medical Inc, an importer/initial distributor in Harrisburg, PA, revealed significant deficiencies in their quality system. The firm was cited for failing to establish written procedures for medical device reporting, complaint handling, overall quality system operations, and corrective and preventive actions. These observations indicate a fundamental lack of documented processes essential for ensuring product quality and regulatory compliance.

## Related Officers

- [Jacob M Dyer](https://www.keypedia.com/people/jacob-m-dyer/e3ca27e3-e0b1-4db8-9cbe-cfaff90b83cf)

Company: https://www.keypedia.com/companies/active-medical-inc/fb7e8063-6b25-4d49-9b83-bd0e65b4e766

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8