FDA debars four QC officials over Able Labs recall scandal
In 2005 Able Labs stopped manufacturing and recalled all its products after the US Food and Drug Administration (FDA) raised “serious concerns” about quality control (QC) data used to win approval. The FDA has now issued five-year debarment orders against four former Able Labs QA/QC staff.
“[The] co-conspirators impaired, impeded, defeated and obstructed FDA's lawful government function to approve the manufacture and distribution of generic drug products by violating good manufacturing practices (GMPs)”, the Agency wrote.
Each of the four Able Labs employees is accused of violating standard operating procedures (SOPs) by “failing to properly investigate, log, and archive questionable, aberrant, and unacceptable laboratory results so that [it] could conceal improprieties and continue to distribute and sell its drug products”.
The FDA goes on to detail specific allegations against the QA/QC officials. Jyotin Parikh, the former laboratory manager in QC at Able Labs, is accused of supervising the creation of false entries in chemist notebooks to support an ANDA (abbreviate new drug application).
Jose Concepcion, the former QC supervisor at Able Labs, is accused of manipulating data related to stability tests for propoxphene napsylate and acetaminophen in December 2001. Ashish Macwan, assistant QC manager, and Shashikant Shah, VP of QA/QC, faced similar accusations from the FDA.
In 2007 Shah was also hit by a US Securities and Exchange Commission (SEC) insider trading lawsuit. The SEC accused Shah of selling close to $1m (€0.75m) in shares of Able Labs over a 16-month period in which he knew about the company’s faulty QA/QC practices.
After Able Labs stopped production in 2005 its share price dropped by 75 per cent. Two months later it filed for bankruptcy protection and by the end of the year had sold its assets to Sun Pharmaceutical Industries.