Food and Drug Administration

GAO reviewed the Food and Drug Administration's (FDA) field laboratories, focusing on: (1) their timeliness in processing product samples to determine if they were violative; and (2) measures FDA could implement to improve this process.

FDA district office investigators collect and ship samples to laboratories for analysis and classification as: (1) compliance samples, which FDA believes are possibly violative; or (2) surveillance samples, collected to obtain safety and other data. To achieve its consumer protection responsibilities, FDA must quickly identify and remove known or suspected violative products from the market. GAO found that FDA: (1) has not given its laboratories sufficient guidance on how quickly they should process such products; (2) does not monitor or evaluate field performance in meeting processing-time guidelines; and (3) has not given the laboratories guidance on managing the flow of samples into inventory or adequately controlling inventory size. Since laboratory documentation requirements add to sample processing time, FDA has allowed abbreviated reports of sample test results in some cases. However, many field laboratories have not used the abbreviated report. GAO previously proposed that Congress consider giving FDA broader detention authority to help keep violative products off the market, FDA believes that the detention period should be the 30 days after sample collection, which would require a shortening of the laboratory processing time to allow time for the necessary legal actions to seize the violative products.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

Director: Team: Phone: