Resources
What is PCQI?
PCQI means Preventive Controls Qualified Individual and is an important part of the Preventive Controls for Human Food Rule (21 CFR Part 117) and Preventive Controls for Animal Rule (21 CFR Part 507). The term is defined in 21 CFR 117.3 and 21 CFR 507.3: A qualified individual who has successfully completed training in the…
Read MoreWhat is FSVP?
FSVP stands for Foreign Supplier Verification Program. FSVP is a regulation that requires importers of most foods to verify the food safety practices of their foreign suppliers. When did FSVP go into effect? The Foreign Supplier Verification Program regulation went into effect for most importers on May 30, 2017. Why did the United States require…
Read MoreIs Coconut an Allergen? FDA Allergen Labeling Requirements
The Food Allergen and Consumer Protection Act of 2004 (P.L. 108-282) requires major food allergens to be labeled on all packaged foods that are under the jurisdiction of the U.S. Food and Drug Administration (FDA), including dietary supplements. Tree nuts are one of the major food allergens defined in the law. Is coconut an allergen?…
Read MoreFDA FEI – What you need to know
What is an FDA FEI? An FDA FEI is a ten-digit number also known as an FDA Establishment Identifier. The number issued by FDA for purposes of tracking business locations subject to FDA regulations. FEI numbers are issued to food, drug, dietary supplement, medical device and biologics establishments, for example. How do I find my…
Read MoreFSVP Enforcement: The #1 Reason for 483s
FSVP Citations The Foreign Supplier Verification Program (FSVP) rule is enforced by the U.S. Food and Drug Administration (FDA) far more than any other regulation within its authority. The FSVP regulation went into effect in May 2017 and FDA ramped up enforcement in 2019. From Fiscal Year 2019 to FY2024, 32.4 percent of the top…
Read MoreFCE SID How Does FDA Regulate Canned Food?
The U.S. Food and Drug Administration (FDA) has special registration requirements for facilities that produce low-acid canned foods (LACF) and acidified foods (AF). This post addresses the items below: What is a low-acid canned food? A low acid canned food (LACF) is any food (other than alcoholic beverages) with both a finished equilibrium pH greater…
Read MoreDUNS Number: Why Food Businesses Need One
Food companies exporting to and doing business in the United States, are likely to be asked a DUNS number (aka D-U-N-S Number®). Let’s review the key points about these numbers: What is a DUNS number? DUNS is the Data Universal Numbering System known as D-U-N-S®. It is a nine-digit unique identifying number for business locations.…
Read More