Digitek Update May 2008: When Old News Is Better Than No News At All

A Month After FDA Class 1 Digitek Recall, We Have Been Told Little About Actavis Manufacturing Problem

(Posted by Tom Lamb at DrugInjuryWatch.com)

More than thirty days have passed since Actavis Totowa first announced the Digitek recall that was issued due to an apparent quality control problem at their manufacturing plant in Little Falls, New Jersey -- not somewhere in China, as numerous patients have presumed during our initial discussion about the situation.

Being that Actavis and the FDA are being relatively closed-mouth about the extent of the manufacturing problems with Digitek that resulted in the production and release of tablets with too much digoxin, we have been looking for information from other sources.

One item that got our attention was a March 1, 2007 article, "Actavis Totowa nets warning for QC, cleaning validation.", written by Joseph Pickett and published by Validation Times.

In relevant part, this article describes how quality control at the Actavis facility in New Jersey where Digitek was made had been an issue as far back as the summer of 2006:

A July 10-Aug. 10, 2006 inspection of Actavis Totowa, Little Falls, NJ, a prescription drug manufacturer, found significant deviations from [Good Manufacturing Practices (GMP)] regulations which included the following:

Significant deficiencies in the company's quality control unit;....

Regarding quality control, FDA investigators noted in the Feb. 1 warning letter numerous instances where the quality control unit failed to adequately investigate and resolve laboratory deviations and out-of-specification (OOS) test results involving drug products that ultimately were released for distribution into interstate commerce. Additionally, investigators uncovered out-of-specification test results in laboratory raw data that were not documented in laboratory notebooks, and found that products were released based on retesting without any justification for discarding the initial out-of-specification test results.

Numerous instances were observed where manufacturing process deviations occurred and in-process specifications were not met, yet there was no indication that action was taken promptly to investigate or to correct the deviations and the products were approved for release and distribution by the quality control unit, the agency wrote....

FDA stated that it had reviewed the firm's corrective actions promised in a letter dated Aug. 29, 2006. The agency found that while corrections the firm promised in its correspondence appeared to adequately address many of the GMP violations, FDA reiterated its concern about the quality of drug products that were released from the facility under the serious lack of GMP controls found during the inspection.

Further, the agency stated that the company should promptly initiate an audit program by a third-party having appropriate GMP expertise, to provide assurance that all marketed lots of drug products that remain within expiration have their appropriate identity, strength, quality, and purity.

One wonders whether or not the FDA-suggested "audit program" was ever implemented by Actavis. 

Given that production and release of double-dose Digitek pills were the types of things this audit was intended to prevent, I am skeptical.