Drugs

CGMP, Other Issues at Washington Homeopathic

A 6/18-7/2/19 FDA inspection at Washington Homeopathic Products, Berkeley Springs, WV, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other issues. A just-released 6/19 Warning Letter says the specific CGMP violations were:

failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, including drug products manufactured, processed, packed, or held under contract by another company, and failing to establish adequate written responsibilities and procedures applicable to the quality control unit;
failing to conduct at least one test to verify the identity of each component of a drug product; and
failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods.

The letter says the firm’s quality systems are inadequate and says that while it acknowledges that the company has hired a consultant, the agency strongly recommends engaging a qualified consultant to assist the company in meeting CGMP requirements.

FDA also identifies several of the firm’s homeopathic drug products that, based on uses for them stated on the company’s Web site, indicate that they are unapproved new drugs. “Homeopathic drug products are subject to the same regulatory requirements as other drugs,” the letter says, and “nothing in the Federal Food, Drug, and Cosmetic Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or approval.”

Washington was told to respond with a list of steps it has taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome