FDA Compliance for Food Companies

mdi Consultants FDA compliance service line for food companies, assists you in bringing your products to market quickly, and to maintain your food company’s FDA compliance status. By using mdi Consultants’ result oriented methodology, mdi has helped food companies achieve and maintain their FDA compliance.

mdi’s FDA Regulatory Strategic Planning Service

Given that we understand the product development process, the FDA submission process and the interplay between these processes, we can craft a regulatory strategy based on your situation. This strategy will include thinking through what actions you take, what you document, what submission process to take, how to structure your clinical trial, etc.

Below is a listing of mdi Consultants Specific FDA Food Compliance Services

mdi Consultants FDA Food Compliance services

HACCP Consulting Services

At the current time, HACCP is required for the food industry under the new FDA food safety regulations and ISO 22000.

Please visit our HACCP Services page.

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How mdi can assist you with FDA Regulatory Services

Many clients underestimate the economic value of a carefully thought out FDA regulatory strategy. Because of our experience and understanding of the FDA, through careful planning we can help you to:

Assist companies in determining their compliance to the 21 CFR 110 – Food cGMP, 21 CFR 117 – CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK–BASED PREVENTIVE CONTROLS FOR HUMAN FOOD, and 21 CFR 111- Dietary Supplements as well all supplemental Processing Regulations for LACF, Acidified Food, Juice HACCP, Seafood HACCP for food manufacturers.
Assist in the development and/or review of the firm’s HACCP Program. This include evaluating or performing the Hazard Analysis and HACCP Plan in addition to the Standardized Sanitation Operating Procedures (SSOPs) associated with the HACCP requirements, as required.
Be available for FDA inspections.
Respond to FDA 483 and Warning letters.
Provide introductory training for staff members in cGMP and HACCP requirements. mdi currently is not able to provide certified training in HACCP related programs.
Food labeling review.
Food established registration and US Age.
HACCP.

FDA Quality System Implementation Services

There are 5 key elements to an FDA quality system: quality manual; quality procedures; work instructions; product quality plans; and, production level quality records. mdi can help you prepare, and implement, the entire system for FDA Quality System Regulation (QSR) / Current Good Manufacturing Practices (cGMP) compliance.
We can supply you with a high-quality fully FDA compliant quality system manual, and procedures, that can be customized and implemented for your operation. Our solutions include everything from management review, corrective action/preventive action (CAPA) and complaint handling. The quality system manuals and procedures are easy to read, follow, and implement, with all necessary procedures and forms. We can implement them both electronically, and paper-based.

mdi has been implementing Quality Systems since 1978, and has set up over 500 companies worldwide. We can guarantee your quality system will meet all the FDA requirements. The systems have been continuously inspected by the FDA and have passed each and every audit for compliance to the cGMPs.

cGMP Audits

What mdi’s FDA cGMP Audit Service does for you?

mdi can perform a mock FDA audit of your operations, to determine compliance to the FDA cGMP (Current Good Manufacturing Practices).
Our audit would be performed in a similar manner to an FDA audit, and is performed by former US FDA field investigators, or industry experts with extensive regulatory requirements.
These mock audits serve two purposes: testing your quality system; and, providing recommendations for corrective actions.

mdi can assist you with

Creating customized training programs, geared to your products, and operations.
We have trained thousands of employees over the last 25 years.

Training Services

mdi provides FDA cGMP employee training and internal auditor training.
mdi’s in-house training sessions cover all aspects of FDA regulatory and quality system requirements, including: cGMP compliance, Process Validation, FDA Strategic Planning, Dealing with FDA inspections and how to prepare replies to FDA 483 and Warning Letters.

How does mdi assist you?

Given that mdi has been officially recognized as third party experts by the FDA, we can provide you with an audit that is the same as what you can expect from the FDA.
Having audited hundreds of the companies, we have helped them to go through a real FDA audit successfully.

FDA Liaison Services

An FDA inspection could be one of the most trying times in dealing with the FDA. Mdi’s Liaison Service knows what to expect, interprets the FDA findings, and provides immediate solutions to prevent regulatory actions, which could be critical to the survival of a company, and provide ongoing support, allowing you to interact with our experts throughout the year.

With mdi Consultants’ Liaison Service, and when a FDA event occurs, or a question arises, we are available to help you.

mdi’s Liaison Services staff has successfully navigated numerous companies through FDA inspections both domestically and internationally where the consequences of an actionable inspection could prevent product commercialization.
mdi’s staff of former US FDA field investigators, with over 100 years of combined FDA regulatory experience, provides a professional demeanor to the FDA visit and assists to expedite the inspection in a manner that has been proven over time.
Our regulatory experience in dealing with the FDA is unsurpassed, with successful removals of injunctions, seizures, and warning letters.

How does mdi assist you?

Making these types of decisions requires thought and planning because these decisions will affect the speed and cost of the total implementation, potential savings that could be realized through a quality system implementation and the level of comfort the FDA will have that you are implementing a compliant quality system.