Patent Law

FDA Bans Import of Generic Drugs From Two Ranbaxy Plants

By Stephen Albainy-Jenei

The Food and Drug Administration (FDA) issued two Warning Letters to Ranbaxy Laboratories and an Import Alert for generic drugs produced by Ranbaxy’s Dewas and Paonta Sahib plants in India.

The Warning Letters identify the agency’s concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy’s manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India.

Because of the extent and nature of the violations, the FDA issued an Import Alert blocking any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

The problems at these two Ranbaxy plants relate to deficiencies in the company’s drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products.

The announcement does not impact products from Ranbaxy’s other plants which are not affected by today’s actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.

The 30 drugs affected are posted on the FDA site (Drug List).

One Warning Letter addressed problems at Ranbaxy’s Dewas facility found during an inspection conducted by FDA in early 2008. Specific areas of concern included the following aspects of the firm’s quality control program:

• The facility’s beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
• Inadequate batch production and control records;
• Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
• Inadequate aseptic (sterile) processing operations.

The second Warning Letter addressed the Paonta Sahib facility.This inspection documented various cGMP deficiencies, including the following:

• The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP;
• Inaccurate written records of the cleaning and use of major equipment;
• Incomplete batch production and control records; and,
• Inadequate procedures for the review and approval of production and control records for drug products.

See the Notice here:  FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India

Full post as published by Patent Baristas on September 17, 2008 (boomark / email).