FDA’s observed violations likely to change with new food safety rule

( Photo courtesy of FDA )

The lack of pest control was the No. 1 problem with food facilities inspected by the Food and Drug Administration in fiscal 2017.

However, with new food safety regulations in place for facilities and importers, the fiscal 2018 list of violations may look quite different, according to Russell Statman, executive director for the Registrar Corp., Hampton, Va.

“FDA right now is in the implementation stage (of the) Food Safety Modernization Act, so past inspections don’t focus as much on the FSMA requirements and most companies really weren’t subject to (food safety rules) until September and importers still aren’t until March,” he said in early January.

“You will see it change. I would predict in (fiscal year 2018) you will see more (FSMA violations),” he said.


Violations by rank

The FDA reported the most frequently cited inspection violations and observations on its website.

Inspection violations can result in warning letters, placement on import alert, suspension of facility registration, and other enforcement actions.

According to the FDA, most frequently cited problems resulting in the issuance of an FDA Form 483 — a form indicating likely violations of the FDA regulations — were:

  • Lack of effective pest exclusion (303 violations): Effective measures are not being taken to exclude pests from the processing areas or protect against the contamination of food on the premises by pests.
  • Screening (211 violations): Failure to provide adequate screening or other protection against pests.
  • Sanitation monitoring (203 violations) Insufficient monitoring of sanitation conditions and practices to comply with Current Good Manufacturing Practices.
  • Floors, walls and ceilings (192 violations): Plant not constructed in a way to allow floors, walls and ceiling to be frequently and kept in good repair.
  • Buildings/sanitary (176 violations): Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.



The Food Safety Modernization Act requires FDA to perform a certain number of domestic and foreign inspections per year, Statman said. For example, Statman said FSMA requires FDA to conduct more than 19,200 foreign inspections per year.

“There is no way they can do that,” he said, noting current foreign inspection activity is about 2,400 inspections per year.

Importers never had to be inspected before, and the food safety regulations change that reality.

“Now, importers are being inspected for the first time,” he said, noting that the agency reported performing about 300 importer inspections as of a couple of months ago.

Statman said Registrar, a food safety consulting company, helps importers put in place compliance monitoring of their suppliers, which is required by the food safety regulations. That monitoring alerts importers if their suppliers have been on import alert by FDA or have received warning letters from the agency.

Most importers don’t have to comply with food safety regulations until March, he said.

Importers must have a Foreign Supplier Verification Program for their suppliers, and he predicted the most common issue with importers will be failure to have a program  plan.

“What we have seen already is that most of them, when the FDA shows up, they don’t really have a FSVP plan.”

FDA is determining who to inspect based on U.S. Customs information, and sometimes that information is bad and the wrong entity is named.

Most importers must comply with new regulations by March 19. Importers and retailers are getting up to speed about the regulations, he said.


Rule relax?

The FDA recently announced enforcement discretion for selected rules, particularly the rule determining if a packing facility should fall under the produce safety rule or the preventive controls rule.

However, Statman doesn’t think that pullback on enforcement on that point is a sign the Trump administration wants to reverse regulations already in place.

The FDA has said that suppliers in countries with FDA-recognized food safety systems were expected to have an easier time in shipping to the U.S., but that may not be the case.

The FDA has said that companies in good standing with food safety authorities in Canada, Australia and New Zealand will have fewer regulations to face. Right now, none of the three countries recognized by FDA has a list of companies in good standing, Statman said.

“They all (Canada, Australia and New Zealand) say they are going to get around to it, and they are in discussions with FDA on how to implement this,” he said.

Now exporting companies in those countries will be in the position to have a food safety plan just as if they were in any other country not yet given food safety equivalence by FDA.

Statman said another future issue is water. Growers in the U.S. and other countries are having trouble figuring out how FSMA water standards will apply to them, though he said the FDA is still trying to work with the ag water regulations to make them workable for growers. P