FDA-PMO – “Grade A” Assessment and Certification
Under a joint effort with the FDA accredited firm Harold Wainess and Associates, we can assist private companies and government agencies to determine the level of compliance and certification under the US Pasteurized Milk Ordinance (PMO) – “Grade A” norm. This standard is required to comply with by all producers and processor of dairy products including milk, creams, yogurt and other fermented milks who want to sell their products in the US market. Proper assessment of the current conditions of dairy farms and processing facilities is essential to allow companies to determine and estimate their ability and capacity for exporting these dairy products to the US market.
“FSMA” Preventive Controls Rule & Foreign Supplier Verification Program “FSVP”
Based on the recently adopted law for Food Safety standard and Preventive Controls standards (21CFR117), all food manufacturers who sell their products in the US market must comply with a new set of standards related to Food Safety Programs including Preventive Controls, Hazard Analysis, Critical Control Points in their manufacturing process. In addition, any manufacturer of ingredients to be used for food products made for sale in the U.S. must meet the requirements of the FSVP (Foreign Supplier Verification Program) section of this standard. ADEM’s team of experts can assist food manufacturers in their preparation, design and implementation of comprehensive Food Safety programs. Lack of substantial compliance of this law may represent a denial of entry into the US at the port of entry for any food product.
HACCP Plan Design and Verification
Hazard Analysis and Critical Control Points “HACCP” (21CFR117 & 21CFR120) is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. HACCP is designed for use in all segments of the food industry. Good Manufacturing Practices “GMPs” (21CFR110) are an essential foundation for the development and implementation of successful HACCP plans. Today, HACCP is universally accepted by government agencies, retail establishments, trade associations, and the entire food industry around the world. At ADEM we are certified HACCP plan practitioners and verifiers and can conduct trainings and certifications of in-plant activities.
FDA-IMS Certification for manufacturing of containers for “Grade A” products
All single use containers and packaging of Grade “A” dairy products (milk, cream, yogurts and other fermented milks) are required to be manufactured in compliance with the FDA – IMS standard (Standards For The Fabrication of Single-Service Containers And Closures For Milk And Milk Products of the Pasteurized Milk Ordinance (PMO – “Grade A”)) as established by the US FDA. Our firm’s consultants are officially accredited to perform audits and certifications of these type manufacturing plants and products.
In addition to the mandatory FDA’s food facility registrations, thermally Processed Low-Acid Foods Packaged In Hermetically Sealed Containers commonly known as canned food products or aseptically packaged (Tetra-Pak®) which require no refrigeration during its shelf life (shelf stable products), may be required to obtain processing equipment validations and submit to FDA a documentation to obtain certification by the Acidified and Low-Acid Canned Foods (LACF) as defined by the US-FDA (21CFR108 & 21CFR113). It is also required for all manufacturing establishments of this type to be registered with FDA as a Low Acid Canned Food Canning Establishment (LCE). At ADEM we have the capacity to asses processing facilities and to register credentials and processes to obtain the aforementioned certifications.