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Archive for Tam Nguyen

FDA Drugs

28
Feb

The FDA Drug Approval Process: Ensuring Safety and Efficacy of Medications

Health and consumer safety are always top priorities for every nation. In the field of healthcare, ensuring the quality and effectiveness of medications plays an incredibly important role. The U.S. Food and Drug Administration (FDA) takes the lead in fulfilling this mission through a rigorous and meticulous drug approval process. This article will delve into […]

QMS - GOL

04
Feb

what are the benefits of Quality Management System (QMS) in an organization

In the increasingly competitive business environment, the quality of products/services is a crucial factor determining the success of a company. The Quality Management System (QMS) is an effective tool that helps businesses enhance the quality of their products/services, meet customer requirements, and strengthen competitiveness. To delve deeper into what QMS is and the benefits it […]

Dietary Supplements

04
Feb

FDA Dietary Supplement Requirements: What “Approval” Actually Means (2026)

By Tam Nguyen | CEO, GOL Solution | 24+ years in international trade & cross-border logistics Last Updated: August 2026 13 min 18 sec · Tam Nguyen, CEO, G.O.L Solution · Published 23 June 2025 Chapters 0:00Who this is for 0:32Importer of Record: your first decision 3:06Making the product FDA compliant 5:19Advertising and influencer compliance […]

04
Feb

FDA Regulations Regarding Food Allergy Labels

Food allergies are a serious health issue that can lead to severe reactions, even threatening human lives. One of the best ways to protect individuals with food allergies is to ensure that allergens are clearly labeled on food packaging. In the following article, GOL will provide you with information about the FDA regulations regarding allergen […]

FDA Approval

04
Feb

What is FDA Approval? Which products need FDA approval?

Amidst the growth in the healthcare and food industry, ensuring the safety and efficacy of products has become more crucial than ever. FDA approval, an integral part of this process, functions as a “quality assessment” by the United States Food and Drug Administration. In this article, GOL will delve into FDA approval and the products […]

04
Feb

FDA Regulations on Nutrition Facts Labels

Labeling food is one of the most important measures to protect consumer health. Through food labels, consumers can grasp information about the ingredients, nutritional content, quality, expiration date, and more of the product, enabling them to make choices suitable for their needs and health. This article will provide some basic information about the FDA’s regulations […]

UFI-GOL

04
Feb

What is UFI? Why is UFI necessary when registering with the FDA?

Do you know that food products, pharmaceuticals, and medical devices must be registered with the United States Food and Drug Administration (FDA) before being circulated in the market? One of the mandatory pieces of information to provide when registering with the FDA is the Unique Facility Identifier (UFI) code. So, what is the UFI code, […]

cgmp - GOL

02
Feb

What is cGMP? Things consumers should know about cGMP

In the era of industrialization and modernization, the demand for cosmetic, pharmaceutical, and food products is continually rising. However, there are numerous low-quality products in the current market that do not guarantee the safety of consumers’ health. To address this issue, regulatory agencies have established standards for Good Manufacturing Practices (GMP), including cGMP. This is […]

Requirements of FSVP

02
Feb

What is FSVP? Overview of Foreign Supplier Verification Programs

When mentioning the United States Food and Drug Administration (FDA), people are often familiar with terms such as “FDA approved,” “FDA cleared,” “FDA 510k,” “PMA,” etc. In contrast, the Foreign Supplier Verification Programs (FSVP) are less known but play an extremely important role. In this article, GOL will provide detailed information about FSVP, specifically for […]

FSMA - GOL

02
Feb

Food Safety Modernization Act (FSMA): Complete Compliance Guide for Food Safety Managers (2026)

By Tam Nguyen · CEO, GOL Solution · 24+ years in international trade & cross-border logistics Last updated: August 2026 8 min 35 sec · Tam Nguyen, CEO, G.O.L Solution · Published 13 June 2025 Chapters 0:30Why FDA inspections matter 1:00Documentation requirements checklist 2:05Training and personnel requirements 2:52FSMA/FSVP compliance strategy 3:58Pre-inspection preparation 6:15Understanding inspection results […]