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FDA Compliance for
Food Companies
Our FDA compliance service line enables you to get your
products to market quickly and to maintain your FDA compliance status. mdi
has helped hundreds of companies to achieve and maintain their FDA
compliance. Below, you will see a list of our specific service offerings.
Please click on an item below for more information.
FDA Regulatory Strategic Planning
- What are mdi’s FDA Regulatory Strategic Planning
Services?
- Given that we understand the FDA regulatory
process, we can craft a regulatory strategy based on your situation.
This strategy will include thinking through what actions you take, in
which order you take them, what you document, how to implement your
quality systems, etc.
- How can mdi assist you?
- 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:
1. Plan for an FDA investigation and guide
you in responding to the Agency and their concerns.
2. Properly manage recalls. Recalls can be very costly and
cause terrible damage to your reputation. Identifying and
implementing actions for a recall that would be acceptable to the
Agency can save money, your reputation and duplication of efforts.
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FDA Quality System Strategy
- What are mdi’s FDA Quality System Strategy Services?
- Assuring FDA compliance to quality system
requirements is critical for the success for all companies. The
quality system requirements are defined by cGMP (Current Good
Manufacturing Practices) guidelines which are specified by the FDA.
- The 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.
- 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.
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Quality System Implementation
- What are mdi’s Quality System Implementation
Services?
- There are 5 key elements to a quality system:
quality manual, quality procedures, work instructions, product quality
plans and production level quality records. We can help you prepare
and implement the entire system for FDA cGMP (Current Good
Manufacturing Practices) compliance.
- We can supply you with a high-quality fully FDA
compliant quality 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 manuals and procedures are easy to read,
follow and implement with the necessary procedures and forms. We can
implement them both electronically and paper-based.
- How can mdi assist you?
- mdi has been implementing Quality Systems since
1978, and has set up over 350 companies worldwide. We can guarantee
that the quality system will meet with 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.
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cGMP Audits
- What are mdi’s cGMP Audit Services?
- We can perform a mock FDA audit of your operations
to determine compliance to the FDA cGMP (Current Good Manufacturing
Practices).
- The audit would be performed in similar manner to a
FDA audit and will be performed by former US FDA field investigators.
- These mock audits serve two purposes: testing your
quality system and providing recommendations for corrective actions.
- How can mdi assist you?
- Given that we have been officially recognized as
experts by the FDA, we can provide you an audit that is the same as
what you can expect from the FDA.
- We have audited hundreds of the companies and
helped them to go through a real FDA audit successfully.
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Training
- What are mdi’s Training Services?
- We provide FDA cGMP employee training and internal
auditor training.
- Our in-house training sessions include 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 can mdi assist you?
- We can put together customized training programs
that are geared to your products and operations.
- We have trained thousands of employees over the
last 25 years.
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Validation
- What are mdi’s Validation Services?
- Process Validation - We can assist in the
preparation of the validation protocol, implementing the validation
and interpreting the data to meet with the FDA guidelines.
- How can mdi assist you?
- We can put together complete validation protocols
as well as execute the validations for you. Contact us for more
information on our validation services.
- Our services comply with the FDA’s Analytical
Method Validation (AMV) (including, linear regression analysis,
precision, accuracy, limit of detection, limit of quantification,
specificity and stability indicating determinations) and Analytical
Instrumentation Installation and Operational Qualifications (IQ/OQ's)
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FDA Liaison
- What are mdi’s FDA Liaison Services?
- An FDA inspection could be one of the most trying
times in dealing with the FDA. Knowing what to expect, trying to
interpret the FDA findings and providing immediate solutions to
prevent regulatory actions could be critical to the survival of a
company.
- We provide ongoing support that allows you to
interact with our experts throughout the year. With this service, when
a FDA event occurs or a question arises, we are available to help you.
- How can mdi assist you?
- mdi's staff has successful navigated numerous
companies through FDA inspections both domestically and
internationally where the consequences of an actionable inspection
could prevent product commercialization.
- Our 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. Please see what our clients have had to say about our
services during an audit.
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