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Able Interim Chief Resigns Amid Drug Recall
Able Laboratories (Cranbury, NJ) accepted the resignation last Thursday of company President and interim CEO Robert G. Mauro. Mauro's resignation comes only two months after he replaced Dhananjay G. Wadekar as chief executive.
This is yet another major blow to a company that recently was forced to halt all production and recall all available product after an internal investigation turned up problematic testing procedures. According to a statement posted on the company's Web site, the company is "seeking an appropriate replacement to lead the company in addressing the company’s previously disclosed regulatory issues, including its recall of all products and its suspension of all manufacturing operations." In the interim, Able's board of directors will oversee day-to-day activities carried out by the senior management team.
Last Friday, Able received a list of inspectional observations (Form 483) from the US Food and Drug Administration. 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; and omitting from the annual report information about investigations that may have affected FDA drug approval. Able has stated that it intends to work with FDA to resolve the outstanding regulatory issues, and "is evaluating all potential strategic options available to it in light of the regulatory and financial issues it faces, including the possibility of seeking relief under the bankruptcy laws."
In response to the Form 483, Able stated that it had submitted possible terms for a consent decree to FDA on May 26, and is "prepared to enter discussions toward a decree at FDA's earliest convenience."