FDA Warns Arizona Manufacturer Over Quality Issues

August 20, 2018

The FDA shot Signature Formulations a warning letter arising from an October inspection of the manufacturer’s Phoenix, AZ, facility that revealed cleaning and maintenance deficiencies and failure to test products and ingredients for conformance.

The firm released several OTC topical pain relief drug products — Herbal Muscle Gel, CBD Muscle Gel and Herbal Muscle Mist — without verifying they conformed to their assay specifications and active ingredient label claims. In addition, the facility lacked product release specifications.

The firm also failed to test incoming manufacturing components used in the company’s OTC and homeopathic drug products. Its quality unit neglected to ensure that numerous manufacturing procedures — such as production, sampling plans, testing, and cleaning — were drafted and approved, and didn’t sign off on finished drug product specifications.

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