FDA Inspections: Top Five Violations in FY 2014

On November 28, 2014, the U.S. Food and Drug Administration (FDA) published its Inspectional Observation Summaries for fiscal year (FY) 2014. Registrar Corp put together a list of the top five most frequent violations observed by FDA during food facility inspections. FDA observed the following violations 200 or more times in FY 2014:
1. Lack of Effective Pest Exclusion – This violation occurs when effective measures are not being taken to exclude pests from processing areas and/or protect against the contamination of food on the premises by pests.
2. Sanitation Monitoring – This violation occurs when sanitation conditions and practices are not monitored closely enough to assure conformance with Current Good Manufacturing Practices (CGMP).
3. Screening – This violation occurs when the facility lacks adequate screening of protection against pests.
4. Floors, walls, and ceiling – This violation occurs when the facility’s construction prohibits adequate cleaning and repairs of the floors, walls, and ceilings.
5. Critical Limits – This violation occurs when the facility’s HACCP plan does not list a critical limit that, or lists a critical limit that does not, ensure control of one or more hazards.
It’s more important than ever for food manufacturers to prepare for an FDA inspection now that the number of annual FDA inspections is increasing under the Food Safety Modernization Act (FSMA), an act signed into law in 2011. FSMA created inspection frequency mandates and granted FDA the right to collect reinspection fees. The mandates that FSMA put into place are as follows:
Domestic High-Risk Facilities: FDA must inspect all high-risk domestic facilities within five years of FSMA’s enactment and no less than every three years thereafter.
Domestic Low-Risk Facilities: FDA must inspect all other domestic facilities within seven years of FSMA’s enactment and no less than every five years thereafter.
Foreign Facilities: FDA must inspect 600 foreign facilities within one year of FSMA’s enactment and double the number of inspections every year for the following five years. That means in 2016, FDA will need to inspect at least 19,200 foreign facilities.
The risk of a facility is determined by the products produced by the facility. For example, seafood and sprouts are considered to be high-risk, so a facility producing one of these products may be subject to more frequent inspections. FDA is currently developing a risk assessment for food. In February 2014, the agency published a draft approach for identifying high-risk foods. FSMA requires FDA to publish a list of high-risk foods along with the finalized approach.
Initial facility inspections cost nothing, but if an inspection reveals certain food safety issues, FDA may decide it needs to return for a reinspection to check on the facility’s progress. The FSMA reinspection fee rates for fiscal year (FY) 2015 are $217 per hour for facilities located in the U.S. and $305 per hour for facilities located outside of the United States. The fees are charged for every direct hour spent on the reinspection, including preparation for the reinspection and travel to and from the facility being reinspected.
Domestic facilities do not receive any warning of an FDA inspection. For foreign facilities, FDA will send a notice by e-mail to the facility’s contact person as well as its U.S. Agent. Inspections usually take two days. Day one is often used for introductions, a meeting, a tour of the facility, and for FDA to review documents. On day two, FDA conducts a thorough facility inspection, meets with management, and delivers a form (FDA Form-483) with its inspectional observations, which the facility will have 15 days to respond to.
There are a variety of reasons that FDA may choose to inspect a specific facility. It may be the facility’s time under the FSMA mandates. FDA may have received a complaint or the facility may have a history of non-compliance. A facility could simply be near another facility that FDA plans to inspect, making it a convenient choice. Whatever the reasoning, one thing is for sure: a facility will want to be prepared in order to help avoid the costly fees that could come along with a reinspection.
But how does one prepare? There are numerous aspects to an FDA inspection. FDA will inspect employees, from their health and cleanliness to their wardrobe. FDA will inspect the facility for waste, pests, building maintenance, and more. FDA will consider how certain contents are stored and the availability of certain facilities, such as bathrooms and hand washing stations. FDA will even check over the design and maintenance of equipment. Along with the facility inspection, FDA will check for other compliance related issues such as proper product labeling and a valid FDA registration.
Registrar Corp, an FDA compliance firm, offers various services to help food facilities prepare for an FDA inspection. The firm offers a Labeling and Ingredient Review Service through which Registrar Corp’s Regulatory Specialists will review a product’s labeling for FDA compliance and ensure the listed ingredients are permitted for sale in the United States. Registrar Corp can ensure that a facility is properly registered with FDA and can help develop and review required food safety documents, such as the HACCP plan required for seafood and juice companies. Registrar Corp even offers a Mock Inspection service through which the firm will send a food safety expert trained in FDA inspections to a facility to help it prepare. The Mock Inspection service is free of charge, other than travel and lodging expenses, for Registrar Corp’s U.S. Agent clients when FDA sets an inspection date.
Registrar Corp’s services are always offered on a fixed fee basis, never hourly. To learn more about the FDA inspection process or Registrar Corp’s services, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at http://www.registrarcorp.com/LiveHelp.