FDA Compliance for Food Companies
Our FDA Compliance for Food Companies, assists you in bringing your products to market quickly, and to maintain your food company’s FDA compliance status. By using mdiConsultants’ result oriented methodology, mdi has helped food companies achieve and maintain their FDA FDA Compliance for Food Companies and manufacturers.
mdi’s FDA Regulatory Strategic Planning Service
As FDA Regulatory Strategic planning consultants, we understand the product development process, the submission process, and the interplay between these processes for FDA Compliance for Food Companies; and at mdi, we will craft an FDA 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 for FDA Compliance for Food Companies.
Below is a Listing of our Specific FDA Food Compliance for Food Companies Service Offerings
How mdi can assist you with FDA Regulatory Services
Many clients underestimate the economic value of a carefully thought out FDA compliance for food companies regulatory strategy. Because of our experience, and understanding of the FDA, through careful strategic 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 Agent
HACCP
Please visit our HACCP Services page.
FDA Quality System Implementation Services
- Assuring FDA compliance to quality system requirements is critical for all medical companies. The quality system requirements are defined by QSR (Quality System Regulations) /cGMP (Current Good Manufacturing Practices) guidelines which are specified by the FDA.
- tThe process by which to achieve compliance to these requirements is different for each company. For example, large companies may need to prioritize geographically-different operations based on size/importance and implement systems accordingly. A smaller company may need to prioritize which elements of the quality system to implement first) in order to get in compliance quickly, which is why mdi’d FDA Quality System Implementation Services can help you reach your goals.
cGMP Audits
What mdi’s FDA cGMP Audit Service does for you.
- mdi can perform a mock FDA cGmp audit of your operations, to determine compliance to the FDA cGMP (Current Good Manufacturing Practices).
- Our audit would be performed in 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.
How does mdi assist you?
- Given that mdi has been officially recognized as third party experts by the FDA, we can provide you 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.
mdiConsultants 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.
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.
- Creating customized training programs, geared to your products, and operations.
- We have trained thousands of employees over the last 25 years.
Mdi’s 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 mdiConsultants’ 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 can 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.
Please see what our clients have had to say about our services during an audit, by clicking here.
Product lifecycle
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