The FDA has Issued two 483 Warnings to Ranbaxy Laboratories, LTD.

Armand Rossetti

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This is an explanatory statement taken directly from the FDA Website:

"The U.S. Food and Drug Administration has issued two Warning Letters to Ranbaxy Laboratories, Ltd., an India-based manufacturer of generic drugs, some for the U.S. market. The Warning Letters address the manufacturing conditions at two different Ranbaxy plants in India, Dewas and Paonta Sahib. FDA inspections have shown extensive deviations from U.S. current Good Manufacturing Practice (cGMP) requirements.

Additionally, the FDA has issued an Import Alert, which FDA can use to bar the import of active pharmaceutical ingredients and finished drug products from these two Ranbaxy facilities in India, unless they are shown to be in compliance with the cGMP requirements. "

The FDA provided the following links for accessing:

1. The list of drugs that are under FDA scrutiny

2. The FDA News release

3. The FDA 483 warning letter sent to Ranbaxy's Dewas, India facility

4. The FDA 483 warning letter sent to Ranbaxy's Batamandi (Unit II) India facility

The only drug on the list that would be in critical supply shortage is Ganciclovir. The following is an FDA statement, addressing drug shortages due to the FDA's order for Ranbaxy to cease importing rugs from the affected manufacturing plants:

"Consumers should not be affected by today’s actions. FDA has determined that there should be ample supply from other manufacturers to meet market demands once the Ranbaxy products are no longer available, with the exception of one drug, Ganciclovir oral capsules, an anti-viral drug. Ranbaxy is the sole supplier to the United States of this drug. FDA is generally not preventing the importation of this product to minimize any disruption to the market. However, FDA will work to ensure additional controls are put into place until the company meets U.S. current Good Manufacturing Practice (cGMP) requirements."