Able Laboratories (Cranbury, NJ) filed for voluntary Chapter 11 reorganization in the New Jersey division of the United States Bankruptcy Court on Monday. This announcement comes on the heels of last week’s resignation of company President and interim CEO Robert G. Mauro.
In Late May, the company was forced to halt all production and recall all available product after an internal investigation turned up problematic testing procedures. Citations by the US Food and Drug Administration include Citations include: failure to ensure that all drug product distributed had the safety, identity, quality, and purity that they are represented to possess; failure to reject drug products that failed to meet established standards, specifications, and quality control criteria.
The Chapter 11 filing will allow Able to continue as a company while working with FDA to improve the aforementioned failings, and cover all expenses to vendors and suppliers.
