FDA sends warning letter to Basic Organics

WASHINGTON

Basic Organics, Inc. didn't receive a Christmas gift this month from FDA.

Instead, the agency sent a warning letter to the dietary supplement distributor, informing the company it has violated Current Good Manufacturing Practices (CGMPs).

During an inspection earlier this year, Basic Organics asserted it was exempt from CGMPs because it manufactures its dietary supplements through a contractor, observed FDA, which told Basic Organics it is ultimately responsible for regulatory compliance to the extent it packages, labels and releases the products under its own name.

"Your firm has an obligation to know what and how manufacturing activities are performed, so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution," FDA stated.

In the Dec. 7 letter to Basic Organics Owner Scott Johnson, FDA cited a number of regulatory violations related to packaging, labeling, holding, and distributing operations.

Alleged violations

Some of those alleged violations included the following:

FDA has given Basic Organics the customary 15 days to respond to its letter.