CertLab Blogs

Insights for the food & beverage, cosmetics, OTC, and supplements industries.

How To: OOS Investigation for OTC Drugs & Dietary Supplements

Reviewed and Approved by Dean Cirotta, President - EAS Consulting Group & Executive Director of Regulatory Affairs -...

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How to Conduct an Allergen Gap Assessment

Reviewed and Approved by Tim Lombardo, Senior Director, Food Consulting Services, EAS Consulting Group (A Certified...

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21 CFR 211: Understanding GMPs for OTC Drug Products

Reviewed and Approved by Lisa El-Shall, Senior Director Drugs and Devices, EAS Consulting Group

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Organoleptic and Sensory Analysis in Food Quality Control

Reviewed and Approved by Howard M. Bogner, Sensory Senior Analyst, Certified Laboratories 

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FDA Food Defect Action Levels & Filth Testing

Reviewed and Approved by Pamela Galarza-Goedtel, Supervisor of Food Forensics, Certified Laboratories 

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How to Test for Lead in Spices

Reviewed and Approved by Steven Rogers, Chemistry Manager, Certified Laboratories 

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Master Manufacturing Records & Batch Production Records

Reviewed and Approved by Shelly Blackwell, Senior Director, Dietary Supplement and Tobacco, EAS Consulting Group 

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Antibiotic Residue Testing for Seafood - Avoiding FDA Detention

Reviewed and Approved by Steven Rogers, Chemistry Manager, Certified Laboratories 

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Supplement Facts vs Nutrition Facts: What QA Teams Need to Know

Reviewed and Approved by Maged Sharaf, Ph.D., Senior Director, Labeling, Cannabis and Claims Consulting Services, EAS...

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FDA dietary supplement testing requirements

Reviewed and Approved by Shelly Blackwell, Senior Director, Dietary Supplement and Tobacco, EAS Consulting Group

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Controlling Alicyclobacillus acidoterrestris in Beverages

Reviewed and Approved by Alex Brandt, Ph.D., Chief Science Officer, Food Safety Net Services

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Process Validation for High Pressure Processing (HPP)

Reviewed and Approved by Ben Howard, Laboratory Director, Food Safety Net Services

1-Minute Summary

  • High Pressure...

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Decoding FDA's GRAS and FAP Rules for Food & Beverages

Reviewed and Approved by Tim Lombardo, Senior Director, Food Consulting Services, EAS Consulting Group (A Certified...

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Accelerated Stability Testing for Cosmetics & OTC Products

OTC and OTC-drug crossover products require stability testing, per FDA regulations. And, while FDA doesn’t mandate ...

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Label Claims: A Guide for Food & Beverage Manufacturers

As product label claims play an increasingly important role in informing consumer purchasing decisions, manufacturers...

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Guide to OTC & Cosmetic Stability Testing [+ Free Cheat Sheet]

Stability testing is the process of evaluating a product to ensure that key attributes stay within acceptable...

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MoCRA: What Does it Mean for the U.S. Cosmetics Industry?

MoCRA is here, and it’s reshaping the U.S. cosmetics industry. The MoCRA law covers a wide range of cosmetics and...

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How to Test for Heavy Metals in Food & Other Products

Heavy metals in food always seems to be a hot topic. First it was concern over heavy metals in baby food. Not long ago,...

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Your Complete Guide to Process Validation for Almonds

Every food manufacturer wants to make a safe product. Scan the website of nearly any grower, processor, or...

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How to Read an HTS Code (& Estimate Customs Duties)

Members of the World Customs Organization (WCO), which includes U.S. customs, use the Harmonized System (HS) to...

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Fast, Accurate Microbiological Testing for Tree Nuts

Food safety failures in the almond industry can be catastrophic, so chemistry and microbiological testing for nuts is...

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FDA ITACS: A Tool to Speed Your Next Import

Everyone wants to cut in front of the line, especially when your company's time and money depend on importing shipments...

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Detained Shipment? Following FDA Sampling Guidelines is Key

FDA can detain your imported food products at any time for any reason. Whether for sampling, testing, or detention...

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Aflatoxin Testing: A Guide for Every Almond Producer

Aflatoxins are one of the biggest threats to producing safe, high-quality almonds that growers and processors face....

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USP 797 Sterile Compounding: What You Need to Know About Sterility Testing

Sterility testing and assurance are critical regulatory compliance requirements for 503B facilities that perform ...

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How to Choose an Import Agent for FDA-Regulated Products

Enlisting an import agent is a basic requirement for importers of FDA-regulated products. Import agents are the...

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The Complex World of Allergen Cross Contact & Controls

Although the risk of allergen cross-contact is well understood, the addition of sesame to FDA’s “big nine” list of...

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Importing Food Products into the US (All You Need to Know)

In this post, we will cover a few important points about U.S. customs, the U.S. Food and Drug Administration (FDA) and ...

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Top 5 FDA Entry Submission Errors & How to Avoid Them

Expediting imports of your FDA-regulated products keeps you a step ahead of the competition, with accurate and complete...

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3 Tips For 503B Sterile Compounding Facilities When Choosing a Lab Partner

503B sterile compounding pharmacies are ultimately responsible for their products, even when they outsource quality and

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How to Avoid Allergen Cross-Contact in Food Manufacturing

1-Minute Summary 

  • The FDA's "Big List" includes nine major allergens, highlighting the need for accurate labeling and...

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FDA Import Alerts: How to Get Off a Red List

Import alerts notify U.S. Food & Drug Administration (FDA) personnel that the agency has sufficient evidence that a...

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The Top Challenges for U.S.-Bound Food Imports

One of the most challenging aspects of doing business in the U.S. is navigating the many and varied regulatory...

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Things to Consider When Scaling Up | Part 1: Labeling

Whether it is that recipe that has been handed down from generations, or the one product that is the star of your...

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The Challenges of Controlling Heavy Metals in Baby Food

Food Safety & Quality teams across food industry segments are often tasked with ensuring raw ingredient integrity...

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