# FDA 483 - DIAMOND ORTHOTIC LABORATORY - November 16, 2023

Source: https://www.globalkeysolutions.net/records/483/diamond-orthotic-laboratory/e35ff5af-fbe4-4773-a4ef-3a04c55ced05

> FDA 483 for DIAMOND ORTHOTIC LABORATORY on November 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DIAMOND ORTHOTIC LABORATORY
- Inspection Date: 2023-11-16
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of DIAMOND ORTHOTIC LABORATORY in La Mesa, CA, a manufacturer of orthotic devices, revealed significant deficiencies in their quality management system. Observations included a lack of established procedures for finished device acceptance, inadequate controls for manufacturing materials, and poorly maintained complaint files. Additionally, the firm failed to document personnel training, indicating systemic issues with their operational controls and record-keeping.

## Related Officers

- [Juanj Wu](https://www.globalkeysolutions.net/people/juanj-wu/0d3e8970-b524-49f6-a307-079091b3c91d)
- [Linda Galindo](https://www.globalkeysolutions.net/people/linda-galindo/6bc29df6-192b-4d89-92ae-20cc1660d9ad)

Company: https://www.globalkeysolutions.net/companies/diamond-orthotic-laboratory/f44bae46-224a-4d55-b739-cd87ed2a96f6

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