26
Th4
The process of registering medical devices with the FDA
The process of registering medical devices with the FDA is a crucial step for companies looking to bring their products to market in the United States. With a healthcare landscape governed by stringent regulations and evolving standards, understanding and successfully navigating the FDA registration process is essential for ensuring compliance and facilitating market access. From […]
25
Th4
What You Need to Know About Food Color Additives
Food color additives are everywhere, brightening everything from candies to beverages. But what exactly are these substances, and why are they used? Are they safe? In this article, we’ll explore the essentials about these additives — their types, uses, safety, and the regulations that ensure they meet strict standards. Let’s dive into the vivid world […]
24
Th4
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
Th4
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
Th4
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 […]
29
Th3
What is the frequency of medical device audits by the FDA?
In preparation for an FDA medical device audit, the manufacturer should have a plan in place to identify the necessary documents and records, as well as train employees on how to answer the inspector’s questions. During the audit, the manufacturer should fully cooperate with the FDA inspector and provide them with all necessary information. If […]
29
Th3
What is ISO 13485? Detailed explanation of the standard
In the realm of medical devices, ensuring quality and safety is paramount. One crucial standard that underpins this commitment is ISO 13485. This article, GOL delves into the intricacies of ISO 13485, exploring its significance, implementation, and impact on the medical industry. What is ISO 13485? ISO 13485 is an international standard that applies to […]
29
Th3
How do I get a food import license in the USA?
Do you want to import food into the United States? To do this process, you need to obtain a food import license from the competent authorities. In this article, GOL will provide detailed instructions on each step so that you can complete the food import licensing procedure quickly and accurately. What is an import/export license? […]
29
Th3
What are OTC drugs? Differences between OTC and Prescription
When you’re feeling under the weather or dealing with a minor injury, it’s natural to want relief as quickly as possible. Over-the-counter (OTC) and prescription drugs offer different paths to that relief, each with its own advantages and disadvantages. In this article, Let’s explore the key differences between OTC and prescription drugs with GOL to […]
28
Th3
What is a critical control point (CCP)? 4 types CCP decision trees
Ensuring food safety is a top priority in the food industry. The Hazard Analysis and Critical Control Points (HACCP) system plays a crucial role in controlling potential hazards and ensuring consumer safety. An essential part of HACCP is identifying Critical Control Points (CCPs). So, what exactly are CCPs? What are the 4 types of CCP […]
