FDA Halts Drug Production at Ranbaxy Plant

The agency has ordered the Toansa, India facility of Ranbaxy to halt drug production and distribution.

According to a press release from FDA, the agency has ordered the Toansa, India facility of Ranbaxy to halt all drug production and distribution for the U.S. market. The company is specifically prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs), and the Toansa facility is added to an existing consent decree initially entered against the company in January 2012.

The decree contains provisions to ensure the company complies with current good manufacturing practice requirements at facilities in Paonta Sahib and Dewas, India. FDA added Ranbaxy's Mohali facility in September 2013.

The action taken by FDA comes in the wake of an inspection of the Toansa facility on Jan. 11, 2014. FDA's inspection found several violations, in particular Toansa staff's retesting raw materials, intermediate drug products, and finished API after the items failed analytical testing and then subsequently not reporting the failures. Ranbaxy has been ordered to hire a third-party expert to inspect the Toansa facility.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Analyze Incident Data

    Collect relevant incident data, analyze trends, and generate accurate regulatory reports, including OSHA 300, 300A, and 301 logs, through IndustrySafe’s extensive incident reporting and investigation module.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common training questions.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Industry Safe
comments powered by Disqus

OH&S Digital Edition

  • OHS Magazine Digital Edition - April 2019

    April 2019

    Featuring:

    • ELECTRICAL SAFETY
      Taking the Guesswork Out of De-Energizing Industrial Equipment 
    • VISION PROTECTION
      Four Simple and Effective Ways to Avoid Digital Eye Strain
    • FOOT PROTECTION
      PPE the Automotive Industry Needs to Invest In
    • FIRE SAFETY
      Eliminate 10 Fire Hazards That May Be in Plain Sight
    View This Issue