HACCP PROGRAMS
HACCP is a floor level food safety program, which when properly developed and implemented will greatly reduce the likelihood of injurous foods from entering the marketplace.
FDA Consulting Services can help you develop or streamline an efficient HACCP Program to ensure legal compliance, withstand all reasonable scrutiny, while saving your company time and money.
Contact BILL about our monthly fee maintenance service that keeps you in compliance with the laws and lets you concentrate on conducting business.
If your firm received an FDA Warning Letter, a 483 Form, or is facing an Injunction and Consent Decree as a result of an inspection, we can assist you in negotiating with the FDA and correcting the violations that can lead to very serious consequences.
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IMPORTER
As an importer, you are responsible for ensuring your overseas suppliers are in compliance U.S. HACCP and Sanitation regulations. FDA Consulting Services can help by providing you with:
- Written Verification Procedures
- Affirmative Steps
- Product Specifications
- Letters of Guarantee
- HACCP and SSOP (Sanitation) Program Development
- Correcting ALL "Ethnic Name" Labeling issues
- Audits of overseas producers
- Liaison with regulators to remedy detentions and prevent further action
Our assistance has resulted in:
- Release of detained product
- Salvaging of saleable product from damaged or detained cargo
- Removal of companies from the detention list
- Faster resolution with the FDA
EXPORTER
If your company is exporting into the United States, you must prove that your processing plant is operating in accordance with U.S. HACCP and Sanitation requirements. FDA Consulting Services has helped develop U.S. HACCP Programs in Mauritania, Senegal, Gambia, Cape Verde, Benin, Guinea, Sierra Leone, Vietnam, Honduras, Canada, Norway, Iceland, Thailand, Bangladesh, United Kingdom, and China.
- Developing a United States HACCP compliance program
- On-Site Inspection and Certification of your facility
- Resolve Detention with or without Notice
- Help remove logistical barriers
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LABELING
COOL (Country of Origin & Method of Production), Nutrition, and Allergen Labeling are evolving regulations that require your attention. FDA Consulting Services can audit and develop labels that will comply with all current requirements of the laws, through our strategic alliance with Brooker Laboratories.
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AUDIT PREPARATION
You are in business to make money and nothing is more important than you buyers and bottom line. Most savvy buyers are now requiring that their food suppliers pass third party GMP audits.
FDA Consulting Services can identify the strengths and weaknesses in your GMP programs, policies, procedures and recordkeeping, when the outcome is critical and preparedness questionable. FDA Consulting Services can help you to develop and implement all the programs, policies, procedures and recordkeeping requirements to ensure high audit scores, keep your valued buyers, and fend off any competition
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SUPPLIER AUDITS
Every supplier will tell you that they are operating in accordance with the applicable laws of their industry, but what assurances do you have other than their word? Protect your brand and check your suppliers thoroughly.
FDA Consulting Services audit your suppliers to ensure they are operating within the law and are meeting your standards and specifications. Here are some Warning Letters as issued by the Food & Drug Administration >>>
BIOTERRORISM ACT
By now, if your facility manufactures, processes, packs, holds or imports food intended for consumption in the United States you should be familiar with the Bioterrorism Preparedness and Response Act of 2002, and what is required of your company.
We can help your company with all phases of compliance.
QUALITY MANAGEMENT
FDA Consulting Services will help you to develop and maintain any level of Quality Management program within your company. Contact Bill (617-308-7611) for monthly maintenance fee quotes.
PLANT DESIGN/MODIFICATIONS
Building or Modifying your food facility? – FDA Consulting Services will work with you or your design team to ensure that all aspects of the Food Codes in your area are built into your plant design, or modifications.
REGULATORY LIAISON
Federal, State or Local regulators can be intimidating and costly without proper representation. FDA Consulting Services can act on your behalf to smooth out any problems, make sure that proper written notifications have been submitted, and corrective actions are completed in a timely manner. We will also argue a point for you, based on scientific or historical evidence. More > >
LITIGATION
In some cases, seeking strong legal representation may be your only option. The goal may be product approval, or to protect or advance a position in the market. Occasionally, the aim is just to prevent current operations from being interrupted.
Action may have been initiated against your company by the Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), US Customs Department (Customs), or the Federal Trade Commission (FTC)
Seeking out the advice of an attorney with little or no experience dealing with the above mentioned agencies can be a costly and critical mistake.
FDA Consulting Services has established a strategic alliance with Christine Humphrey, Esq., an expert in FDA law and partner at Fuerst Humphrey Ittleman. This law firm is the best at in this field.
Whatever your food safety or quality needs FDA Consulting Services is at your service and ready to meet your needs with a work ethic and integrity of days gone by.
