Dr. Rath International, Inc., based in San Jose, was issued eight citations from the Food and Drug Administration (FDA) following a March 26 inspection regarding Food Composition, Standards, Labeling and Econ, the FDA’s website shows.
FDA records list the following citations delivered to the company:
- ‘Personnel engaged in labeling, holding and performing quality control operations for dietary supplements are not qualified to do so.’
- ‘You did not establish written procedures for quality control operations.’
- ‘Your products received for packaging or labeling as a dietary supplement records did not contain the required documentation.’
- ‘You did not control the reconciliation of any issuance and use of label discrepancies.’
- ‘You did not assign a batch, lot, or control number to each lot of packaged and labeled dietary supplement from a finished batch of dietary supplement.’
- ‘You did not establish written procedures for holding and distributing operations.’
- ‘You did not follow written procedures for the requirements to review and investigate a product complaint.’
- ‘Your review and investigation of a product complaint did not extend to all relevant batches and records.’
The FDA regularly inspects facilities nationwide to assess whether workplaces and products comply with laws and regulations under its jurisdiction, which are established to promote public health. Inspection results are made public.
The agency states on its website that it is mainly responsible for overseeing the safety and quality of human and animal drugs, biological products, medical equipment, and tobacco products.
This report includes information from the U.S. Food and Drug Administration. The source data is available here.
