FDA Compliance Group LLC

Your solution to FDA compliance needs
FDA Compliance Group is located in Denver, Colorado

Food And Tobacco ~ FDA Consulting Services

At FDA Compliance Group, our FDA consultants have worked for the FDA or have extensive experience in the food and tobacco industry.

In order to help you reach and maintain full FDA compliance with all regulations and requirements, we provide the FDA consulting services listed below.

Food

GMP / HACCP Compliance Audits
We can assess the level of FDA compliance of your manufacturing, quality, and laboratory systems (including sanitation / GMP, low-acid, acidified, shell eggs, HACCP, and drinking water regulations) and provide instructions for how to become fully compliant. We can perform gap analyses, HAACP verification, sanitation / GMP inspections, and supplier / co-packer audits. From beginning to end, we can assist with all aspects of food manufacturing requirements.

FDA Inspections and FDA Warning Letters
In the event that you receive a FDA Form 483 (Inspectional Observations) or an FDA Warning Letter, we can step you through the response process. In most cases, a well-formulated, written response can prevent further FDA regulatory actions. With FDA inspections, we can assist you every step of the way, from pre-inspection preparation to onsite support during the inspection.

FDA Reportable Food Registry / FDA Recalls
We can show you how and when to file reports using the Reportable Food Registry within required timeframes and provide guidance so that your record keeping and recall procedures are complete and in control. In case of a product recall, we can advise you on the necessary steps to take.

FDA Imports / FDA Detention
We can assist you with all import operations, as well as provide guidance if products have been detained and/or fall under automatic detention (DWPE).

FDA Process Authority
If you are a Low Acid Canned Food (LACF) and/or Acidified Foods processor, we can help you establish processes and procedures for foods that are safe and in compliance with FDA regulations.

FDA Staff Training
We can customize FDA training for your business or organization on issues such as: HACCP / GMP compliance, FDA inspection readiness, updates for the FSMA (Food Safety Modernization Act), and quality systems. We can also provide contracted management services.

Tobacco

Section 906(e) of the Tobacco Control Act of 2009 provided that the FDA would develop regulations for: GMP / HACCP, pre-production design and control, and testing raw tobacco for pesticide chemical residues.

Our FDA consultants can help you become compliant not only with the 2009 act, but with all aspects of the tobacco industry that are regulated by the FDA, including:

GMP / HACCP Compliance Audits
We can assess your manufacturing, quality, and laboratory systems and provide guidance on developing a quality system, appropriate to the tobacco industry, pre-regulation.

FDA Inspections and FDA Warning Letters
We can help you fully prepare for an FDA inspection (from pre-audit readiness to onsite support during the inspection). We can also help you craft a response to an FDA Form 483 (Inspectional Observations) or FDA Warning Letter. Typically, a robust written response to 483s and Warning Letters can head off further FDA regulatory action.

FDA Imports / FDA Detention
We can assist you with your import operations, as well as provide guidance if products have been detained and/or fall under DPWE (automatic detention).

Pre-Production Design Control
We can provide training in design controls, with emphasis on pre-production design control, so that you can begin the design process with FDA terminology and regulations in mind.

Nonclinical Trials and Laboratory Operations
We can assist you with the development of non-clinical trials (in-vivo and in-vitro), including: CRO selection, trial evaluations, study monitoring training, and complete 21 CRF, part 58 training. We can audit onsite, as well as contract laboratories, for compliance with the FDA's current GMP requirements, in the absence of specific tobacco laboratory requirements. This will allow your laboratory and testing procedures to be ahead of the game when the specific FDA requirements are implemented. It can also give you the opportunity to comment on proposed requirements, using specific date to back up your observations.

For more information on FDA consulting services for food and tobacco products or to schedule a consultation, please contact us.