Able Laboratories Suspends Operations and Recalls Product Line Amid Internal Review and FDA Investigation

Strategic Insights -

Able Laboratories, Inc., a pharmaceutical company based in New Jersey, has suspended its manufacturing operations and recalled its product line due to apparent departures from standard operating procedures and noncompliance with current good manufacturing practices. The company had previously announced several product recalls earlier this year due to improper laboratory practices. In an effort to address these issues, Able has initiated an internal review and is working with external consultants and the FDA to ensure compliance with regulatory requirements.

As part of its ongoing investigation, Able will continue to review its entire ANDA (Abbreviated New Drug Applications) portfolio and will withdraw other previously approved and pending ANDA applications if it identifies further data upon which the company is not willing to rely. The recall of all products and suspension of manufacturing operations are expected to have a material adverse effect on the company's business and results of operations.

Key Takeaways:

  • Able Laboratories has suspended its manufacturing operations and recalled its entire product line due to apparent departures from standard operating procedures and noncompliance with current good manufacturing practices.
  • The company had previously announced several product recalls earlier this year due to improper laboratory practices and noncompliance with standard operating procedures.
  • Able is working with internal management resources, outside consultants, and the FDA to ensure compliance with regulatory requirements.
  • The company intends to withdraw seven of its approved Abbreviated New Drug Applications (ANDAs) filed with the FDA for various reasons, including commercial reasons and the identification of data upon which the company is no longer willing to rely.
  • Able will continue to review its entire ANDA portfolio and will withdraw other previously approved and pending ANDA applications if it identifies further data upon which the company is not willing to rely.
  • The recall of all products and suspension of manufacturing operations are expected to have a material adverse effect on the company's business and results of operations.

Statistics:

  • The company has recalled its entire product line consisting of unknown quantities and values.
  • Able has initiated an internal review and is working with external consultants and the FDA to ensure compliance with regulatory requirements.
  • The company has suspended shipment of its products for an undisclosed period of time.
  • Seven Abbreviated New Drug Applications filed with the FDA will be withdrawn due to commercial reasons and data reliability concerns.
  • The impact of the recall and suspension of operations on the company's business and results of operations is expected to be significant and material.

Sources:

  • Ability Laboratories, Inc. press release dated May 23, 2005 (PRNewswire-FirstCall)
  • Annual Report on Form 10-K for the year ended December 31, 2004 (SEC filing)
  • Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 (SEC filing)