Beverage, Food, and Medical Support
Some common FDA violations are for missing/inadequate procedures or inadequate quality systems. Check out our programs for industrial gas companies to learn how we can help you run a compliant and responsible operation.
General FDA Consulting
Our technical and regulatory support is one of the key elements that set B&R Compliance Associates apart from other FDA consulting firms. B&R has a vast amount of regulatory and manufacturing experience with diverse backgrounds that include analytical chemistry, engineering, operations management, and business leadership.
FDA Audit & Agency Interaction Assistance
We have successfully guided both small and large firms in repairing their compliance programs and image with the FDA following an enforcement action. If you have a 483, a warning letter, or worse, B&R can show you how to get moving on the right track. With our support and guidance, you can also be more effective in managing your interaction with the FDA.
Whether you are involved in a product recall, preparing a recall effectiveness report, submitting a med watch report, or are involved in an FDA compliance action, B&R Compliance Associates can help you effectively manage the process.
Federal Site Registration and Listing
Any site that:
- Manufactures, repacks, relabels, or salvages drugs
- Manufactures, prepares, or processes biologics
- Produces and distributes medical devices
must register each establishment and list these products with the FDA. B&R offers federal registration and listing services for your business.
Each facility manufacturing, processing, packing, or holding food/beverage for consumption must register with the FDA. B&R Compliance Associates offers federal registration services for your business.
(Food and Drug)
Current Good Manufacturing Practices (cGMP) are required by the FDA to ensure sanitary processes for any food/beverage and drug manufacturer or service provider. These regulations cover hygiene, plant design, equipment, operations, quality management, and process controls. Additionally, the Food Safety Modernization Act (FSMA) requires hazard analysis and risk-based preventive controls.
Anyone who manufactures, processes, packs, or holds food/drugs must undergo cGMP training, per 21 CFR 117.4.
Beverage Quality and Food Safety
B&R supports new and established companies with the implementation, maintenance, and improvement of their food safety & quality systems.
We are recognized by the FDA as “Preventive Control Qualified Individuals” (PCQI) and provide consulting and training for the development, implementation, and management of food safety plans.
Food and Beverage Gas Applications
B&R provides compliance and regulatory support to the food and beverage industries, as well as a broad range of other markets. Whether you are developing a safety or GMP compliance program, need to review and assess your current capabilities, or are seeking a professional resource partner to support your existing programs, we provide the expertise and in-depth experience you need.
FDA Risk Assessments
The Food Safety Modernization Act (FSMA) mandates that every company involved in the production, preparation, packaging, or distribution of food and beverages conducts a risk assessment of their facilities/products and implements appropriate risk-based controls.
B&R assists companies with Hazard Analysis and Critical Control Points (HACCP) or Hazard Analysis and Risk-Based Preventative Control (HARPC) programs as part of their overall food safety plan. We help you identify potential hazards and develop appropriate risk-based controls to minimize or eliminate risks.