# FDA 483 - Stoner Incorporated - November 15, 2023

Source: https://www.keypedia.com/records/483/stoner-incorporated/caf5e6bb-f092-4791-a122-be851ffc30db

> FDA 483 for Stoner Incorporated on November 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stoner Incorporated
- Inspection Date: 2023-11-15
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Stoner Incorporated in Quarryville, PA, revealed significant deficiencies in their quality system for medical device manufacturing. Observations included a lack of an approved device master record, insufficient finished product acceptance activities, and unsupported product expiration dates. Additionally, the firm failed to implement its own design control procedures for medical devices.

## Related Officers

- [Investigations](https://www.keypedia.com/people/edward-d-mcdonald/69224613-2b96-426a-99dd-e1cfe5ff1713)

Company: https://www.keypedia.com/companies/stoner-incorporated/4acead35-d94e-4f78-a8d9-5f0a072af618

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