EXPORT TO THE USA

FDA REQUIREMENTS

 

CAPT collaborates with a team specialized in FDA requirements. For companies that export or wish to export their products to the United States, CAPT offers a wide range of services tailored to each company’s needs:

FDA REGISTRATION (BIOTERRORISM ACT)

Bioterrorism Act

The events of September 11, 2001, reaffirmed the need to enhance the security of the United States, including its food supply. In response, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, commonly known as the Bioterrorism Act, signed into law by President Bush on June 12, 2002. There are four main sections of this law that affect food and beverage companies, but for practical purposes, only two significantly impact Central American exporters: a) Company Registration and b) Prior Notice Notification.

Registration. Section 305 requires that, as of December 12, 2003, any company that manufactures/processes, packs, or stores food or beverages for human or animal consumption in the United States must be registered.

FDA image 3

CAPT offers the following services:

  • Company registration with the FDA and U.S. Agent (Bioterrorism Act)
  • Renewal of FDA registration and U.S. Agent services (Bioterrorism Act)

LOW-ACID CANNED FOODS (LACF) / ACIDIFIED FOODS (AF)

To distribute and sell non-perishable low-acid canned foods (LACF) and acidified foods (AF) in the U.S., the FDA requires each facility to obtain a Food Canning Establishment (FCE) registration. Producers must also submit scheduled processes—known as Process Filing—for each product, product style, processing method, container type, and size. Each process filing receives a Submission Identifier (SID). To import AF and LACF, both FCE and SID are required.

Registration. Each LACF/AF production facility must register with the FDA to obtain an FCE number. Processors must then submit a separate scheduled process (SID) for each product and container size. All registrations must follow FDA forms.

CAPT offers the following services:

  • Facility registration
  • Product registration
  • Execution of FDA-required tests based on product type and thermal process

CONSULTING – HACCP, PROCESSES, GMP

FDA Federal Regulations establish a series of requirements based on product type and processing methods. While all food industries maintain a Hazard Analysis and Critical Control Points (HACCP) system, the FDA has developed reference guides that all companies exporting to the U.S. must follow.

CAPT offers the following services:

  • Consulting for HACCP manual development according to FDA requirements
  • Process adaptation to FDA standards
  • Validation/verification of processes per FDA guidelines
  • Internal audits (Third-party audits)
  • Preparation and/or support during FDA inspections

FDA image 4

TRAINING

The FDA mandates specific training for certain roles with responsibilities or relevance to processing.

Our training:

  • Delivered by highly qualified staff with over 14 years of experience
  • Designed and tailored to company needs and attendee profiles
  • Based on practical methodologies for immediate application

CAPT offers the following courses:

  • BPCS (Better Process Control School)
  • PCQI (Preventive Controls Qualified Individual)
  • Seafood HACCP
  • U.S. Labeling

MANAGEMENT OF SUBSIDIZED TRAINING

CAPT offers its clients a free service for managing their courses through FUNDAE – the State Foundation for Employment Training (formerly the Tripartite Foundation).