Friday, July 10, 2009

Caraco to Eliminate Nearly 350 Employees Due to FDA Seizures

Caraco Pharmaceutical Laboratories has announced that it will eliminate approximately half of its employees and curb overhead by suspending all manufacturing following the seizure by the US Food and Drug Administration (FDA) of up to 33 of the company's generic drugs due to manufacturing violations. This is anticipated to impact over 350 employees.

In June 2009 the FDA seized drugs made at the company's Michigan facilities in Detroit, Farmington Hills and Wixom. The seized drugs included generic versions of heart, pain and psychiatric drugs as well as the epilepsy treatment Tegretol and a generic copy of the diabetes drug Glucophage.

Earlier in 2009 Caraco had been charged with repeated violations of FDA’s current Good Manufacturing Practice (cGMP) requirements. Beginning in January 2009, Caraco initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

XStream Systems endorses the concept of material screening of pharmaceuticals from raw materials, through the various points of production, within the distribution supply chain and at the point of dispense.

Validation at all points of the pharmaceutical supply chain from the manufacturer to the consumer verifies quality and protects against counterfeiting, fraud and adulteration.

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