# FDA 483 - ONCORE - SAN MARCOS dba NEOTECH - March 06, 2020

Source: https://www.keypedia.com/records/483/oncore-san-marcos-dba-neotech/efd3ac43-ea4a-4360-b341-6124b974d9e0

> FDA 483 for ONCORE - SAN MARCOS dba NEOTECH on March 06, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ONCORE - SAN MARCOS dba NEOTECH
- Inspection Date: 2020-03-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of ORTHOCORE - SAN MARCOS dba NEOTECH, a contract manufacturer in San Marcos, CA, revealed three observations. The firm was cited for inadequately maintaining complaint files, failing to establish adequate process control procedures, and not properly controlling nonconforming products. These issues indicate deficiencies in documentation and adherence to established manufacturing processes.

## Related Officers

- [Jenny L Mccardell](https://www.keypedia.com/people/jenny-l-mccardell/b8fa04db-6acc-48d1-b0be-56777704ae51)

Company: https://www.keypedia.com/companies/oncore-san-marcos-dba-neotech/d8b66587-e912-4677-a5fa-51846eacca5c

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6