Walmart has made its $4 prescription program — in which customers can get 30‐day supplies of a range of common medications for $4 — a key component of its effort to change its image from “rapacious, money‐hungry global megacorporation” to “friendly fun‐time global megacorporation.” But a new investigation by WakeUpWalmart.com raises a serious question about how the retail giant manages to offer these $4 prescriptions.

WakeUpWalmart reports that in order to profit on the $4 prescriptions, Walmart imports the drugs from cheap overseas suppliers. One of the suppliers, India’s Ranbaxy Laboratories, has been repeatedly investigated by the Food and Drug Administration and the Department of Justice for “inadequate” safeguards against contamination, falsifying records and submitting false information to the FDA. The situation was so bad that in 2008 the FDA banned drugs from two Ranbaxy plants and in 2009 halted review of applications from a third:

2009 Violations

In February 2009, the Food and Drug Administration announced it had halted review of importation applications for generic drugs manufactured at Ranbaxy’s Paonta Sahib plant owned by Ranbaxy Laboratories, LTD, an Indian generic drug manufacturer, “due to evidence of falsified data.” According to the FDA press release, Ranbaxy “falsified data and test results in approved and pending drug applications.” In the warning letter sent to Ranbaxy, the FDA cited seven examples of false statements made by Ranbaxy to the FDA. According to FDA records, this was the third time Ranbaxy’s Paonta Sahib facility had run afoul of federal Food and Drug laws.

The FDA did include a caveat in its release, stating that the agency “has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.”

A week after the FDA announced it was halting review of Paonta Sahib applications, Canada announced it was “quarantining” all drugs produced at the Paonta Sahib plant.

2008 Violations

Previously, in September 2008, the FDA issued warning letters to Ranbaxy regarding “significant deviations” from FDA standards for the manufacture of drugs sold in the United States. According to an FDA press release, the agency also banned the importation of any Ranbaxy drugs produced at the company’s Dewas and Paonta Sahib plants.

According to the release, the Dewas plant’s cross-contamination prevention program was “insufficient.” These programs are designed to prevent cross-contamination between different types of drugs. The plant also used “inadequate” sterilization procedures and performed “inadequate failure investigations.” According to the FDA release, failure investigations are performed “to address any manufacturing control or product rejection to determine the root cause and prevent recurrence.” The Paonta Sahib plant had “inaccurate” records regarding cleaning and maintaining of its equipment and “incomplete” records.

Deborah Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, announced that the “severe violations” had led the FDA to ban importation of drugs from these plants and to deny any new drug import applications for drugs manufactured at these plants.

Before the warning letters were sent and the sanctions put in place, Ranbaxy had the opportunity to rectify the problems at the Dewas and Paonta Sahib plants; however, the company’s “response failed to adequately address multiple, serious deficiencies.”

2006 Violations

The FDA had issued a previous warning letter in June 2006 to Ranbaxy regarding “significant deficiencies” in the Paonta Sahib plant’s “stability testing program.” According to Ranbaxy documents produced under subpoena, Ranbaxy was first notified of the violations by the FDA on February 25, 2006.

During the FDA’s inspection of the Paonta Sahib plant, the agency found fourteen instances where equipment cleaning records were signed by employees who “were not shown as present by security log records.”…

Download the complete report and take action at WakeUpWalmart.com.