FDA Blasted Again by the Office of the Inspector General – Consequences for Industry
Updated: Nov 20, 2018
The title of the Office of Inspector General (OIG)'s report on the status of FDA inspections since the implementation of FSMA pretty much says it all. That is: "Challenges Remain in FDA’s Inspections of Domestic Food Facilities."
At a high level, this report does not make the FDA look good and should create a “watch out” to industry of what FDA is likely to do in response to the report.
Let me set the scene by reminding everyone about the OIG report from last year. In 2016, FDA was blasted by the OIG for being slow to move on recalls. The result of that was swift and significant with the Agency pushing firms hard for recall actions. This most recent report is inherently no different in that FDA is being made to look bad, and I predict they will respond to this report quickly and decisively.
So what does the report say? Basically, the OIG were tasked with assessing how FDA is doing with facility inspections. This was both in the context of meeting FSMA requirements as well as following up on observations. The report says that although FDA is on track to meet the domestic food facility inspection timeframes for the initial cycles mandated by FSMA, it is inspecting fewer facilities now than in the past, requirements are increasing for the future, and inaccuracies have been discovered in the Food Facility Registration data causing FDA to arrive at facilities that are out of business or not currently in operation.
It definitely looks like "challenges remain"! But it may not be so bad if the only problem was that the FDA was not going to meet Congressional expectations on inspections. Unfortunately, OIG's investigation also showed that:
FDA did not always take action when it uncovered significant inspection violations, i.e., “Official Action Indicated” (OAI).
When it did take action, it commonly relied on facilities to voluntarily correct the violations.
FDA rarely took advantage of the new administrative tools provided by FSMA.
The agency's actions were not always timely, and did not always result in the correction of these violations.
It did not include consistent timely follow-up inspections on correction of significant inspection violations: Follow-up inspections for nearly 50% of those with the violations took more than a year; for 17%, no follow-up inspection was conducted at all.
One clear example from the report is this section:
“For example, FDA cited one facility for preparing its food under unsanitary conditions. FDA observed rainwater leaking through the roof, directly above where food was being prepared, as well as cracks and holes in the walls and floor that prohibited adequate cleaning. The inspection revealed the presence of Listeria monocytogenes in the facility, a dangerous pathogen that can cause life-threatening illness. Soon after the inspection, FDA issued a warning letter to the facility requesting prompt correction of the violations; however, these violations went uncorrected over the next 2 years. Three subsequent inspections documented that the facility did not correct the violations, and FDA continued to find unsanitary conditions and the presence of Listeria monocytogenes.”
OIG’s report was based on analysis FDA’s food facility inventory and inspection data, beginning started with the lists of high-risk and non-high-risk facilities that FDA created for each inspection cycle. Then the extent to which FDA inspected—or attempted to inspect— these facilities was determined. Attempted inspections occur when an investigator visits a facility but it is out of business or not in operation – but FDA counts those facilities in its inspection numbers related to meeting the mandates. Reading between the lines, I don’t think OIG really approved of that strategy and saw it as a cop out by FDA, and a failure of the data systems to accurately capture who is doing business in the US.
OIG stated that the study data came from: information about facilities that FDA designated high risk and non-high risk pursuant to FSMA, and whether these facilities were inspected as required; FDA’s food facility inventory and inspection data from 2010 to 2015; information about FDA actions such as warning letters and seizures taken in response to significant inspection violations, and follow-up inspections conducted; and structured interviews with FDA officials.
As I noted above, OIG also is now reviewing FDA’s monitoring of domestic and imported food recalls, due to concerns it raised in a June 2016 early alert memorandum that FDA does not have adequate policies and procedures to ensure that facilities take prompt and effective action in initiating voluntary recalls. In that report, OIG suggested that FDA update its recall staff instruction to establish set timeframes for FDA requests for voluntary food recalls and firms to initiate those recalls. FDA reported that it expedited changes to improve voluntary recall compliance and strengthen its enforcement strategies.
According to FSMA mandates, FDA is to inspect domestic food facilities within certain timeframes: high-risk facilities are to be inspected within five years for the initial inspection cycle, and every three years thereafter; non-high-risk facilities are to be inspected within seven years for the initial inspection cycle, and every five years thereafter.
By the end of 2015, FDA had inspected—or attempted to inspect—all but nine of the of the domestic facilities it had designated as high-risk facilities. Additionally, with two years remaining in the initial seven-year cycle for non-high-risk facilities, FDA inspected—or attempted to inspect— about two-thirds (40,623) of these facilities. FDA officials maintain that the agency can inspect the remaining facilities by the end of 2017, and OIG believes that FDA appears to be on track to do so.
However, with the timeframes that FDA is required to meet being shorter by two years in the second and subsequent cycles than they were for the initial cycles, non-high-risk facilities pose a challenge for future cycles. That is, OIG states, unless FDA increases its current pace of inspections of non-high-risk facilities, it will not be able to meet the mandates for future inspection cycles.
From its observations, OIG recommends that FDA:
Improve how it handles attempted inspections to ensure better use of resources.
Take appropriate action against all facilities with significant inspection violations.
Improve the timeliness of its actions so that facilities do not continue to operate under harmful conditions.
Conduct timely follow-up inspections to ensure that significant inspection violations are corrected.
According to the report “FDA concurred with all four recommendations.” Of course, FDA concurred – what else could they do?
So what's next? If the 2016 OIG report about recalls is anything to go on, we can expect FDA to come down very hard on facilities that have violations and to follow up aggressively. Likely some companies will be made an example to get everyone in line. Maybe we will see more suspensions of registration – I would not be surprised. But to all those reading this, my message is that if FDA inspects your plant and issues you with a 483, you have to pay very, very close attention to addressing the issues that the regulators found. If you don’t address the 483 issues then you may be the “example” they will focus on.
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com