Overview

Grand River Aseptic Manufacturing, Inc. specializes in the production of injectable pharmaceuticals, providing sterile contract filling and analytical services. The company is a key partner for pharmaceutical companies looking to bring their products from development to market.

Core services & business areas

Aseptic Fill and FinishSterile Injectable ProductionAnalytical TestingQuality AssuranceProject Management

Therapeutic areas

Injectable PharmaceuticalsSterile Products

FDA compliance signals

8 FDA enforcement records linked to this company.

  • 4832025-11-04

    Validation lacking for sterile drug products

  • 4832025-11-04

    Procedures not in writing, fully followed

  • 4832025-11-04

    Procedures not in writing, fully followed

  • 4832025-11-04

    Control procedures to monitor and validate performance

  • 4832014-11-24

    Procedures for sterile drug products

  • 4832014-11-24

    Procedures not in writing, fully followed

  • 4832014-11-24

    Equipment Design, Size and Location

  • 4832014-11-24

    Training , Education , Experience overall

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