# FDA 483 - Ortho & Surgical Solutions, Inc. - November 22, 2019

Source: https://www.globalkeysolutions.net/records/483/ortho-surgical-solutions-inc/f79bd2cf-fb6b-4267-9965-89d05002010b

> FDA 483 for Ortho & Surgical Solutions, Inc. on November 22, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ortho & Surgical Solutions, Inc.
- Inspection Date: 2019-11-22
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Ortho & Surgical Solutions, Inc. in Guaynabo, PR, was inspected by the FDA from November 18-22, 2019. The inspection revealed a recurrent observation regarding inadequate record-keeping practices. Specifically, the firm failed to document the person delivering human tissue products to surgical sites and the dates of these entries in their distribution records.

## Related Officers

- [Laura E. Garcia](https://www.globalkeysolutions.net/people/laura-e-garcia/ad7c9bee-bbff-494f-b9cf-35c3a04316c0)

Company: https://www.globalkeysolutions.net/companies/ortho-surgical-solutions-inc/1dbdadaa-77a6-4aff-85ea-1789487cd527

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6