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FDA sends warning letter to Basic OrganicsFDA sends warning letter to Basic Organics

Basic Organics faces alleged violations from FDA regarding failure to identify quality control personnel, failure to prepare and follow a written master manufacturing record and more.

December 18, 2012

1 Min Read
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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:

  • Failure to identify quality control personnel and establish and follow written procedures for the responsibilities of the quality control operations

  • Failure to prepare and follow a written master manufacturing record

  • Failure to establish and follow written procedures for product complaints

  • Failure to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that the company distribute

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

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