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Health Technology gets FDA warning letter for GMP and alleged label violations

27-Nov-2012
Last updated on 28-Nov-2012 at 18:36 GMT

Health Technology, Inc., from Dawson, Georgia, has received a warning letter from the Food and Drug Administration for alleged GMP violations, and failing to include contact details on the labels of some of its products.

In a letter dated November 15 , FDA states that, during a recent inspection of its facilities, the company:

-  “failed to prepare and follow a written master manufacturing record (MMR)”,
-  “failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement for each dietary supplement that you manufacture”,
-  “failed to make and keep written records for the production and process control system requirements that apply to components, packaging, and labels”,
- and six other areas of good manufacturing practice (GMP).

In addition, the Agency noted that three of the company’s products were misbranded […] because the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplements.”

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