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483
•RMR Ortho LLC

FDA 483 - RMR Ortho LLC

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Record Details

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.

Company
RMR Ortho LLC
Product Type
Device
Office
Division of Human and Animal Food Operations - West III
Person
  • Jason Markwardt
View Company Profile

ID · 22bbe18a-ceb7-4677-a964-07931571fdfb

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