# FDA 483 - GRAMERCY EXTREMITY ORTHOPEDICS - October 06, 2022

Source: https://www.keypedia.com/records/483/gramercy-extremity-orthopedics/c071ca7b-00e2-4f5d-b196-8ec65bf8fcda

> FDA 483 for GRAMERCY EXTREMITY ORTHOPEDICS on October 06, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GRAMERCY EXTREMITY ORTHOPEDICS
- Inspection Date: 2022-10-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: During an inspection, GRAMERCY EXTREMITY ORTHOPEDICS, a medical device manufacturer in Richardson, TX, was cited for inadequate procedures for receiving, reviewing, and evaluating complaints. The firm failed to consistently gather additional product information for failure analysis and did not establish proper procedures to determine if complaints required Medical Device Reporting to the FDA, indicating significant quality system deficiencies.

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## Related Officers

- [Katlin N. Stubbs](https://www.keypedia.com/people/katlin-n-stubbs/27d70db1-a2e9-4254-a721-c6de655f7626)
- [issuing_officer](https://www.keypedia.com/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)

Company: https://www.keypedia.com/companies/gramercy-extremity-orthopedics/7da3f45a-bec3-4e92-89a6-08ac1f4f3656

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab