Regulatory Compliance Insights: Expert Articles by REJIMUS

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Regulatory Insights and Compliance Resource Archive

Laboratory personnel in protective head coverings and gloves inspecting bottles during a GMP quality control

Flawed Specifications & FDA Inspections
Ensuring the quality and safety of products begins with the raw materials used in their manufacture. However, developing and maintaining appropriate raw material specifications often presents significant challenges; the same goes for any critical in-process components or materials.

Wooden blocks spelling "GMP" alongside pills and capsules, illustrating the importance of GMP certification

What YOUR GMP Certification IS and IS NOT
In an industry where trust is everything, the rise in FDA Warning Letters to companies that either posses a GMP Certification for their facility or that are wholly reliant on their vendors that do, reveals a startling truth: not all that glitters is gold.

Scientist in protective gloves carefully handling raw materials and ingredients for quality control, supporting FDA

The New New Dietary Ingredient Notices
The fact remains that ALL New Dietary Ingredients require NDI Dossier assembled and on file (formerly known generically as an NDI “Master File”), and these were generally to be filed by the supplier of the NDI without intention to sell a Dietary Supplement finished product themselves.

Gloved hand holding a pen and completing a quality control inspection form, illustrating preparation

Preparing for an Unannounced FDA Inspection
The FDA plays a crucial role in ensuring the safety and efficacy of food, drugs, medical devices, and other regulated products in the United States. To fulfill this mission, FDA conducts inspections and audits of facilities and processes involved in the production, distribution, and sale of these products.

Close-up of gloved hands carefully dispensing liquid into a jar, illustrating quality control processes

The Future of Cosmetics Regulation: Navigating MoCRA Compliance
In the ever-evolving landscape of cosmetics regulations, staying ahead of the game is essential. We understand the importance of keeping your cosmetic business compliant with the latest regulations and ensuring the safety of your products for consumers.

Dietary supplement capsules moving along a production line, illustrating GMP compliance and quality control processes

Common Non-Compliance Issues and How to Address Them
In the expansive world of dietary supplements, ensuring the safety, purity, and efficacy of products is crucial. The U.S. Food and Drug Administration (FDA) has established Good Manufacturing Practices (GMPs) under 21 CFR Part 111 to set the standards for the production of these supplements.

Close-up image of pharmaceutical capsules in blue and white, illustrating FDA compliance and GMP requirements

Key Differences Between Drug and Dietary Supplement GMPs
In the realm of health and wellness, both pharmaceutical drugs and dietary supplements play integral roles in improving and maintaining our health. However, the manufacturing standards governing these two categories differ significantly.

Assorted colored capsules and pills representing dietary supplements, illustrating the importance of GMP compliance

Understanding 21 CFR Part 111: GMPs for Dietary Supplements
The world of dietary supplements is vast, offering a plethora of products that claim to improve health, manage symptoms, and enhance physical or cognitive performance. Given the widespread use of these products, ensuring their safety and quality is of paramount importance.

Individuals taking notes during a regulatory training session, highlighting the importance of employee training

The Importance of Employee Training in Ensuring Food Safety in Your Manufacturing Facility
Food safety is a primary concern in any food manufacturing facility. It’s a vital component that ensures the well-being of consumers, which maintains the reputation of the company. Central to achieving and maintaining high standards of food safety is the role of employee training.

Close-up of a gloved hand holding a clipboard with a checklist, representing quality control

How to Develop a Food Safety Plan for Your Manufacturing Business
In the food manufacturing industry, the implementation of an effective food safety plan is pivotal. It not only safeguards consumer health but also ensures regulatory compliance and protects your brand reputation. In this article, we provide our input on the key components and importance of a comprehensive food safety plan.

Assortment of food and beverage products, including canned goods, oils, milk, and packaged foods, illustrating

Types of Recalls
In the realm of product safety and consumer protection, one term stands paramount: product recalls. This process is a key mechanism to safeguard consumers from products that may pose significant health risks, including those in the dietary supplements and food & beverage industries.

A person holding a jar of food product being filmed with a professional video camera

Top 5 Things to Watch Out for when Advertising a Product
In today’s world, where people are more health-conscious than ever, the market for food and dietary supplement products is growing rapidly. In this article, we will discuss the top five things that companies should keep an eye out for when marketing a food or dietary supplement product.

Cosmetic product filling process in a manufacturing facility, illustrating FDA regulatory compliance and quality control

What is MoCRA?
The regulation of cosmetics has not kept up with the pace of innovation, leading to potential health hazards and concerns. To combat this, the Modernization of Cosmetics Regulation Act of 2022 was passed to expand the FDA’s authority of regulating cosmetic products.

Close-up view of hands typing on a laptop, illustrating FDA compliance and regulatory procedures

Why Manufacturers Need to Register Their Facilities With the FDA
As a Food company that manufactures, processes, packs, or stores food, the primary reason for registering your facilities with FDA is a requirement to ensure compliance with federal regulations, specifically the Food Safety Modernization Act (FSMA).

Food manufacturer conducting inspection of processing equipment and raw materials, highlighting potential FDA inspection violations

Common FDA Inspection Violations
As a dietary supplement or food manufacturer, it is critical to be aware of the most common inspection violations noted by the FDA during a facility inspection. By being informed and implementing preventative measures, you can avoid costly fines and potentially harmful consequences. Here are some common inspection violations to be aware of.

Person in pink lab coat and blue gloves reviewing a clipboard during a GMP audit

The Benefits of a Third-Party Audit
As a food or dietary supplement manufacturer, it is important to ensure that your facility and operations are in compliance with all applicable regulations and standards. A third-party audit is one way you can guarantee compliance and the safety of your products. Here are just some of the benefits why a third-party audit can be beneficial to your company.

Bottled dietary supplements moving along a conveyor belt, illustrating FDA labeling requirements and quality control

Understanding FDA Label Requirements for Dietary Supplements
As a dietary supplement manufacturer, it is imperative to understand and comply with the FDA labeling requirements to ensure the safety and quality of your products. In this article, we walk you through the required basic information that your company must include on your labels in order to follow the regulations set forth by the FDA.

Food production worker in blue protective gear inspecting product on a manufacturing line, ensuring FDA

How can you make food products safer?
Ensuring the safety of food products is an essential task for food producers and manufacturers. With the increasing demand for food, it is necessary to make sure that the food being produced and consumed is safe for human consumption. Here are some ways your company can ensure the safety of your food products.

Magnifying glass highlighting "FDA" over a binder and clock, illustrating FDA compliance and regulatory review

What are Warning Letters?
A warning letter is a public formal notice issued by the U.S. Food and Drug Administration (FDA) to companies that have violated federal laws and regulations. The purpose of a warning letter is to bring the violation to the company’s attention and to give the company an opportunity to take corrective action to bring its products and practices into compliance.

Close-up image of various dietary supplement capsules and tablets, including brown, yellow, and white capsules

FDA and Structure/Function Claims
Is your company getting ready to market or launch a new dietary supplement product? If so, it is crucial that you notify the FDA about any structure/function claims you plan on including on your label. In this short article, we will discuss what structure/function claims are, why you need to notify the FDA, as well as how to submit these claims to the FDA.

Man eating a healthy meal with a protein shake, water bottle, and supplements, illustrating

What are GRAS and NDI Notifications?
Ensuring the safety and compliance of your products is vital in today’s regulatory landscape. In our latest post, we explore the differences between Generally Recognized as Safe (GRAS) and New Dietary Ingredient (NDI) notifications, and the importance of proper regulatory compliance.

Woman in lab coat and glasses inspecting bottles during FDA inspection, highlighting quality control

What are 483 Observations?
If you manufacture, process, package, or distribute food, beverage, or dietary supplement products you could be subject to FDA Inspection. As a result, your company may receive an FDA Form 483. In this article, we define what an FDA Form 483 is as well as steps to mitigate the risk.