What does FDA require drug manufacturers to do to prevent contaminated drugs? If contamination occurs, how must they correct the problem?

To prevent contamination and ensure product quality, FDA requires companies to follow Current Good Manufacturing Practice regulations (CGMPs) for manufacturing drugs.  If contamination is discovered during production of a drug, manufacturers must not distribute the product and must correct the problem, using a “corrective action plan.”  Sometimes, however, contamination is discovered after distribution.  If this occurs, FDA expects manufacturers to recall affected batches, investigate, and take measures to prevent it from happening again.  When a batch is recalled, FDA:

• Asks the company to stop shipping and to recall product that has already been shipped;
• May take samples for analysis to find the contamination's source and may also use the company's production records to find out the extent of how much product could be involved;
• Conducts a health hazard evaluation (HHE) to determine how the public might be affected;
• Works with the company to issue public notices and recall alerts;
• Oversees the company’s corrective action plan, which can include re-inspection by FDA and contacting distributors and retailers to ensure product is recalled.

FDA cannot order a firm to recall a drug. If a company will not cooperate with a recall or investigation, FDA can take regulatory action.  If FDA finds contamination because the manufacturer did not follow CGMPs, FDA may take enforcement action that can include issuing warning letters, seizing product, obtaining court orders to prevent further manufacturing, or even criminal fines and jail time.  FDA may also request a state regulatory body to take action.