Able interim CEO walks as FDA sends in 483
executive in six weeks on Friday, after Richard Mauro tendered his
resignation.
The company, which has been forced to recall all its product lines and suspend manufacturing as a result of quality problems at its Cranbury, New Jersey facility, also said on Friday it was on the verge of filing for bankruptcy, sparking a further massive drop in its share price.
The company's shares are currently worth under $2, down from a level of nearly $25 before news of the recall broke in May.
Able was forced to cease all its manufacturing and recall products after major problems emerged with its quality control procedures at its manufacturing plant in mid May, prompting the resignation of former CEO Dhananjay Wadekar. Since then, the company has announced sweeping job cuts, cutting around half its workforce of 420 staff.
The company has also published a copy of the Food and Drug Administration's Form 483, which details the extent of the problems at the plant. This form, which is generated on the basis of an inspection of the facility, details a number of problems with Able's quality assurance procedures, but draws two primary conclusions: the quality unit lacked authority to investigate errors, and did not reject products failing to meet quality criteria.
A letter sent to the agency in response to the 483 notice suggests that the best recourse now open to the company is to agree to a 'consent decree', which would allow it to continue operating - under the eye of the FDA - as it attempts to bring its processes in line and bring product back onto the market.
