Courtesy of SeafoodNews.com:
GAO released a report on Friday recommending that the FDA monitor whether it’s following procedures and meeting goals for their imported seafood warning letters.
The FDA sends out warning letters to companies that violate food safety regulations and pose a public health risk. The warning letters generally ask the company to describe the steps being taken to correct the violation, and ask the company to respond with how it plans to correct the issue within 15 working days.
In addition, the FDA set a goal to conduct follow-up inspections within six months of issuing the warning letter to ensure that the violations highlighted were corrected. However, GAO says that based on warning letters that the FDA sent from 2014 to early 2019, they did not consistently follow key procedures or meet key goals. GAO claims that of the 125 warning letters sent for significant inspection violations during that time period, only 14 received follow-up inspections within the six month period. Of those 125 letters, 56 received follow up inspections from the FDA more than 6 months after the warning letter was issued. GAO says the average for that visit was two years. The remaining figure has yet to receive a follow-up inspection from the FDA as of March 11, 2020.
“While FDA has some monitoring tools, the agency does not have a monitoring process that allows it to determine whether all imported seafood warning letters (to both domestic and foreign firms) consistently follow procedures and meet goals, and FDA officials stated the agency had not conducted such a review of all letters,” GAO reports.
GAO is recommending that the FDA commissioner establish a process to monitor whether the agency is “consistently following key procedures and meeting key goals for its imported seafood warning letters, and take corrective action when necessary.” GAO is also recommending that the FDA commissioner develop performance goals and measures to assess the effectiveness of its warning letters in ensuring the safety of imported seafood. An example would be reviewing the “percentage of warning letter cases that have been resolved, either through a closeout letter or import alert placement, within one year of being issued.”