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483
•Custom Interventional Pain Management, LLC

FDA 483 - Custom Interventional Pain Management, LLC

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Record Details

An FDA inspection of Custom Interventional Pain Management, a device manufacturer in San Antonio, TX, revealed significant deficiencies across its quality management system. Observations included failures in supplier evaluation, management review, internal quality audits, and corrective and preventive action procedures. The firm also lacked adequate procedures for evaluating and processing complaints, with many complaints remaining open without justification.

Company
Custom Interventional Pain Management, LLC
Product Type
Device
Office
Division of Human and Animal Food Operations - West III
Person
  • Gilbert Valdez (investigator)
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ID · a7964261-31c6-4a7f-a229-70b2b7352f75

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