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FDA sends more GMP-related warning letters to four dietary supplement manufacturers

By Stephen Daniells , 14-Feb-2013

Four dietary supplements have received independent warning letters from the Food and Drug Administration for alleged GMP violations, as the agency maintains its focus on compliance.

Florida-based Consolidated Marketing Unlimited, Inc. was sent a warning letter dated January 10, 2013 for “serious violations of FDA’s Current Good Manufacturing Practice in the Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements (CGMP)”.

A selection of the alleged violations include:
1. Failure to identity test the ingredients,
2. The company did not prepare and follow a written master manufacturing record for each unique dietary supplement formulation,
3. The company did not establish and follow written procedures for calibrating instruments and controls used in manufacturing or testing a component or dietary supplement,
4. Failure to implement a system of production and process controls to cover all stages of manufacturing, packaging, labeling, and holding of your dietary supplements, and
5. Incomplete batch production records.

To read the full warning letter, please click here .

M.D.R. Fitness Corp.

Sunrise, FL-based M.D.R. Fitness Corp. received a letter dated January 29, 2013 for failure to comply with cGMP regulations.

The agency also warned the company about claims on the company’s website that promote products “for conditions which cause the products to be drugs”.

The GMP violations included:
1. Failure to make and keep written procedures for maintaining, cleaning, and sanitizing equipment and utensils that are used to package, label, or hold components or dietary supplements.
2. Failure to make and keep documentation of the date of use, maintenance, cleaning and sanitizing of equipment in individual equipment logs, unless such documentation is kept with the batch record.

To read the full warning letter, please click here .

Scilabs Nutraceuticals, Inc.

Irvine, CA-based Scilabs Nutraceuticals, Inc. received a letter dated January 25, 2013 for “serious violations” of the GMP regulations.

Alleged violations included:
1. Failure to establish required quality control specifications for select points, steps, or stages in the manufacturing process.
2. Failure to test the identity of dietary ingredient components, and to confirm the identity of other components. 
3. Failure to prepare and follow a written master manufacturing record for each unique formulation of a dietary supplement
4. Failure to complete a batch production records
5. Failure to establish and follow written procedures for calibration of instruments and controls

FDA also alleged the company misbranded dietary supplements by failing to “include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplements”.

To read the full warning letter, please click here .

Genesis Herb Company, L.L.C.

A letter date February 6, 2013 warned Monroeville, OH-based Genesis Herb Company, L.L.C. of alleged GMP violations and misbranding of dietary supplements.

The violations included
1. Failure to establish and follow written procedures for the responsibilities of the quality control operations.
2.  Failure to prepare and follow a written master manufacturing record for each unique dietary supplement formulation.
3.  Failure to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement
4.  Failure to establish and follow written procedures for holding and distributing operations.
5.  Incomplete batch production records.
6.  Failure to test the identify of dietary supplement ingredients.

The company was also warned about misbranded dietary supplements because select products were not identified as “dietary supplements”, and other products did not include a “Supplement Facts” panel on the label.

To read the full warning letter, please click here

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