U.S. FDA Announces Reinspection Fees Fiscal Year 2018
The U.S. Food and Drug Administration (FDA) recently published the hourly rates for the reinspection of food facilities during fiscal year (FY) 2018. The cost of reinspection for a domestic facility is $248 per hour, a $27 increase from FY 2017. The cost for a foreign facility is $285 per hour, the same as in FY 2017.
The total cost of a reinspection depends upon the amount of time FDA performs inspection-related duties. This may involve preparation for the inspection, travel to and from the facility being inspected, the physical examination of the premises, and any sample analysis or lab work required. Reinspection fees can quickly add up to thousands of dollars, especially for facilities in countries where travel alone can take a day’s time. To avoid these potentially high reinspection fees, it is prudent to take measures to ensure that proper food safety procedures are in place when FDA inspects a food facility the first time.
What is a reinspection?
When a food facility registers with FDA, it grants FDA permission to inspect the facility at any given time. Initial FDA food facility inspections are of no cost to the facility and may occur due to routine reasons, a facility’s level of potential risk to public health, or as a response to a problem or complaint.
If FDA discovers certain food safety violations during an initial inspection, the Agency may decide it needs to return at a later date to evaluate whether the facility implemented appropriate corrective actions. This second evaluation is considered a reinspection (also sometimes referred to as a “compliance follow-up inspection”).
The frequency at which initial FDA inspections occur may continue to increase in response to mandates under the 2011 Food Safety Modernization Act (FSMA). FSMA directs FDA to inspect domestic facilities at a rate determined by the risk its products pose to public health. High-risk facilities are to be inspected every three years, while low-risk facilities are to be inspected every five years. FSMA also directed FDA to increase its annual inspection of foreign facilities. FDA provides foreign facilities with notice that an inspection of the facility will occur. Domestic facilities may receive no notice at all. Regardless, it is crucial for all facilities to take steps to be prepared for the initial FDA inspection at all times.
What factors could warrant a reinspection?
FDA’s most recently published data on commonly occurring inspection violations at food facilities indicates food safety issues that FDA may likely search for while inspecting a facility. The most frequent violations in FY2016 included:
- Lack of Effective Pest Exclusion / Screening – FDA cites a facility for not taking effective preventative measures against pest presence in food processing areas or not implementing controls to protect food from contamination due to pests.
- Sanitation Monitoring – FDA cites a facility for failing to effectively monitor sanitation practices and conditions consistently.
- Floors, Walls, and Ceilings – FDA cites a facility for being constructed in a way that inhibits proper sanitation and repair of the floors, walls, and ceilings.
- Importer Verification – FDA cites a seafood importer for failing to document verification of a supplier’s compliance with Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations.
- HACCP Plan Implementation – FDA cites a facility for failing to implement procedures established in its written HACCP Plan. It is important to note that following the compliance date in September 2016, FDA is now likely to also check for proper implementation of Hazard Analysis and Risk-based Preventative Control (HARPC) Plans at most food facilities.
Several violations in the above list were just as frequent in 2015 as they were in 2016. Registrar Corp urges food facilities to examine these issues and take the appropriate measures to prevent FDA citations for these and similar food safety problems.
Proper preparation for an initial inspection may reduce the chance of FDA citing a facility for violations that can cause return visits. Having a third party trained in FDA inspections review your facility for violations is often an invaluable business decision. Poor results from an initial inspection not only can result in an expensive reinspection, but also in Warning Letters and other public information that could damage a brand’s reputation. While there may be costs associated with third-party assistance, it is likely more affordable than the alternative.
Registrar Corp offers a Mock FDA Inspection service in which our Food Safety Specialists identify potential food safety problems and educate staff on FDA expectations. This Mock FDA Inspection service is included as part of Registrar Corp’s U.S. Agent service at no charge, aside from lodging and travel expenses.
For questions or assistance with FDA compliance, call Registrar Corp at +1-757-224-0177. Additionally, you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.