X-Frame-Options: SAMEORIGIN
: 516-482-9001

Food Industry Regulatory Consulting

FDA Food Regulations & Compliance

mdi Consultants provides expert food industry regulatory consulting services to help companies navigate FDA requirements, ISO compliance, HACCP compliace, food safety regulations, and labeling standards. Our team supports food manufacturers, importers, and distributors in meeting U.S. and global regulatory requirements from product development to market entry.  mdi Consultants ensure your products comply with evolving food safety laws while streamlining approval processes and minimizing risk.

For food companies, we offer the following regulatory consulting services:

The mdi NEWS & INFO section provides information links to all you need to stay up-to-date on industry information. You will find our Insight Report, which includes commentary and analysis on important regulatory issues. We also have information on FDA recall and updates as well as a comprehensive list of important industry links.

You can browse our client list or view our client testimonials for more information on the results we have delivered for other companies.

FAQ's

Postpone an FDA audit

The FDA just contacted you to let you know that they intend to inspect you facility next week; you are not sure why they are coming and if you would be able to pass the inspection.

If you get mdi involved immediately, mdi may be able to get an extension for the upcoming audit. mdi will ask the FDA certain questions to ascertain the FDA’s objectives with their audit. Based on the response of the FDA, we can help you to craft a strategy to have the audit postponed or to prepare for the audit itself.

This can be especially useful for non-U.S. manufacturers, where the FDA gives up to 30 days notice of an upcoming inspection.

Respond to an FDA Audit / FDA 483 Response

The FDA just finished their inspection and you just received a FDA 483, the FDA’s List of Observations. This List of Observations contains deviations that the FDA found during their visit.

mdi will provide you with an explanation of these deviations, what their implications might be, and what regulatory actions the FDA may likely take against your company (i.e. Warning Letters, Seizure, Injunction). A proper response to a FDA 483 must be done within a matter of days and must be written in a specific manner to greatly reduce the likelihood of receiving a Warning Letter in the future.

For non-U.S. manufacturers, the issuance of a Warning Letter could lead to an import alert which requires an automatic product detention of all shipments of products coming from your company into the U.S.

Health Hazard Analysis Response – Product Removal or Corrective Action

To notify the FDA or not?

You have found out that there is a problem with your product. It has injured someone or you believe that it could injury someone. Now what do you do? Understanding the problem, brainstorming corrective actions, and performing an FMEA should all be done before you take any external actions. You must be prepared to act and have a logical strategy to give to the FDA.

We will help you to identifying your options, correctly assess the FDA’s concerns, respond to the Health Hazard Analysis, and prepare for a pending FDA visit.

Speak with a Food Regulatory Expert

mdi Consultants – Your Trusted FDA Consulting Partner