# FDA 483 - RMR Ortho LLC - Unknown Date

Source: https://www.keypedia.com/records/483/rmr-ortho-llc/22bbe18a-ceb7-4677-a964-07931571fdfb

> FDA 483 for RMR Ortho LLC on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RMR Ortho LLC
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: RMR Ortho, LLC, a medical device manufacturer in San Antonio, TX, was cited for failing to implement adequate quality requirements for its contractors. Specifically, the firm contracts with an unregistered entity for manufacturing operations, quality control, and quality system management. This indicates a significant deficiency in their quality system regarding supplier oversight and regulatory compliance.

## Related Officers

- [Jason Markwardt](https://www.keypedia.com/people/jason-markwardt/77cd110b-4520-44b0-9fb4-ca0102b0d10e)

Company: https://www.keypedia.com/companies/rmr-ortho-llc/00e8934c-b58a-4e17-8a95-556f3e9553b1

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