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Current Good Manufacturing Practices & the Private-Label Distributor

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Over the past several years, the Food and Drug Administration (FDA) has focused its attention on compliance issues related to the dietary supplement industry, generally, and on current good manufacturing practices (cGMPs), in particular. Indeed, we have seen an increase in the issuance of 483s and warning letters to Private Label Distributors (PLD) for failing to have adequate standard operating procedures related to cGMPs.

The Federal Food, Drug, and Cosmetic Act (FFDCA) prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated for failure to comply with dietary supplement cGMP requirements (FFDCA § 402(g)). The cGMP regulations are located in Title 21 of the Code of Federal Regulations, Part 111.

To be clear, a PLD is ultimately responsible for products introduced or delivered for introduction into interstate commerce carrying its name and must ensure that the company and products are in compliance with all FFDCA requirements and pertinent regulations. Therefore, along with establishing standard operating procedures (SOPs) the PLD must implement directly, it must also develop oversight SOPs to ensure its contract manufacturing and fulfillment companies are in compliance.

The cGMP regulations provide for broad and general requirements. To the extent that these regulations apply to the PLD, step-by-step how-to instructions and detailed explanations must be identified in the SOPs to implement the cGMP requirement. Below is a broad outline of both the direct and oversight SOPs that a PLD must develop.

Oversight SOPs
As indicated, the agency has issued several warning letters emphasizing the importance of oversight SOPs for dietary supplement cGMPs. The letters stated that a dietary supplement distributor using contract manufacturers or labelers may be liable for cGMP violations by its contractors, explicitly noting that “‘agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever means necessary to ensure compliance with the [FFDCA]’ can be held accountable for violations of the [FFDCA].”

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NutraCap Labs

About NutraCap Labs

OUR MISSION:
NutraCap Labs’ mission is to provide our customers with the highest quality products and an industry-best customer service experience. Based in Atlanta, GA, NutraCap Labs is a manufacturer of Nutraceuticals/Dietary Supplements and we are experiencing explosive growth. As a GMP compliant and an FDA registered company, we specialize in encapsulation manufacturing, sports nutrition and raw health powders, product formulation, brand design and distribution. Private Label manufacturing is the fastest growing sector of our business and our biggest strength due to the relationships we have built with our customers.

OUR GOAL:
Our goal at NutraCap Labs is to partner with our customers to create the best products possible through custom formulation, in-house label design and other services that we offer. Additionally, through our sister company, Active Sports Distribution, we market and sell some of the health and fitness industry’s most popular supplements to retail stores worldwide. With the Nutraceutical industry approaching $85 billion annually, we are excited to become a leader in this arena. Our experienced management team is committed to bringing ethics and professionalism to the forefront of the industry.

At Nutracap Labs we aim to lower what has always been a high barrier to entry into the dietary supplement industry. Our minimums start at 144 units per product and allows lower risk for two categories of customer. 1. Those who may be working with limited capital and cannot tolerate much risk. 2. Those who have the capital but are interested in testing the market before they scale their business

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