09
May
A Guide to Drug Master Files
Among the crucial steps towards FDA approval lies the creation of a Drug Master File (DMF), a comprehensive document that serves as a repository of vital information pertaining to a drug product. This detailed dossier encompasses intricate details about manufacturing facilities, production processes, active ingredients, packaging materials, and other critical aspects of the drug’s journey […]
26
Apr
What is FDA QSR? Differences between FDA QSR and ISO 13485
In the realm of medical device manufacturing, compliance with regulatory standards is paramount. Two key frameworks governing quality management are the Food and Drug Administration Quality System Regulation (FDA QSR) and the International Organization for Standardization (ISO) 13485. While both aim to ensure product safety and quality, they differ in scope, certification processes, and global […]
26
Apr
What is FDA 483? Important Details About FDA 483 Forms
The FDA 483 form plays a crucial role in safeguarding consumer health by ensuring that products manufactured and circulated in the US market meet strict quality and safety standards. In this article, GOL will provide you with important information about the FDA 483 form, including its contents, issuance process, response methods, and consequences of non-compliance. […]
26
Apr
FSSC 22000 – Food Safety System Certification Scheme
In the context of the food industry’s continuous growth and increasing emphasis on food safety, FSSC 22000 certification has emerged as a leading standard, providing businesses with an opportunity to affirm their position and expand their market presence. Recognized by the Global Food Safety Initiative (GFSI), FSSC 22000 is built upon the foundation of ISO […]
26
Apr
ISO 22000 Standard and Essential Information You Need to Know
Food safety is a top priority for consumers and businesses in the food industry. To ensure food safety and meet the increasingly high demands of the market, many enterprises have chosen to implement the ISO 22000 standard. ISO 22000 is a food safety management system issued by the International Organization for Standardization (ISO). This standard […]
26
Apr
What is ultra-processed food? How does it affect health?
In today’s modern food landscape, the term “ultra-processed food” has become increasingly prevalent, sparking discussions and debates about its impact on health. As we navigate through aisles lined with brightly colored packaging and seemingly endless options, it’s crucial to understand what exactly constitutes ultra-processed food and the implications it holds for our well-being. From convenience […]
25
Apr
Food Color Additives: Complete Guide to FDA Regulations and Compliance (2026)
By Tam Nguyen · CEO, GOL Solution · 24+ years in international trade & cross-border logistics Last updated: August 2026 If you manufacture food or beverages sold in the United States, food color additives are one of the most heavily regulated ingredients on your label, and one of the easiest to get wrong. Unlike most […]
24
Apr
How to renew FDA registration? Details on time and cost
Understanding the ins and outs of renewing FDA registration can be daunting for businesses in regulated industries like food, drugs, and medical devices, given the strict deadlines, regulatory requirements, and potential fees involved, all of which are essential for maintaining compliance and ensuring operational continuity. In this article, GOL will delve into the intricacies of […]
01
Apr
What are the consequences of food mislabeling products?
Mislabeling of food products can have far-reaching consequences, impacting both consumers and businesses alike. In today’s highly regulated food industry, accurate labeling is not just a matter of compliance but also a critical aspect of ensuring public health and safety. From allergen exposure to legal liabilities, the repercussions of mislabeling can be severe. This article, […]
01
Apr
What are food additives? Overview about FDA food additives
Food additives are substances added to food to improve or alter their flavor, color, texture, or shelf life. They can be used to preserve food, make it more appealing, or supplement nutrients. Besides that, The United States Food and Drug Administration (FDA) is responsible for ensuring that food additives are safe for consumers. The FDA […]
