# FDA 483 - ORTHO PRECISION PRODUCTS - November 14, 2023

Source: https://www.keypedia.com/records/483/ortho-precision-products/b7296390-6725-4440-a07b-137e67001212

> FDA 483 for ORTHO PRECISION PRODUCTS on November 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ORTHO PRECISION PRODUCTS
- Inspection Date: 2023-11-14
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of ORTHO PRECISION PRODUCTS in Hawthorne, CA, from November 7-14, 2023, identified one observation related to inadequate maintenance of device history records. Specifically, several work orders were found to be missing critical in-process inspection results, dates, and initials. These issues were not addressed prior to lot release, despite internal quality work instructions.

## Related Officers

- [Nancy Bogdanovic](https://www.keypedia.com/people/nancy-bogdanovic/acda7736-9cf7-46e0-ac7b-324fce8705bb)
- [investigator](https://www.keypedia.com/people/juanita-banuelos/b8b581ef-b9f3-4d77-a9fa-691223dbb7f4)

Company: https://www.keypedia.com/companies/ortho-precision-products/394c541a-7687-42e4-93f2-07bd47e38e89

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