AG Hair Limited CGMP Issues

A 6/20-6/24 FDA inspection at the AG Hair Limited drug manufacturing facility in Coquitlam, BC, Canada, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. An 11/28 Warning Letter says specific violations were:

• failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
• failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
• failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.

The letter notes the firm manufactures products containing ethanol and glycerin, both of which have led to lethal poisoning incidents in humans worldwide.

FDA acknowledges the company’s commitment to cease the production of hand sanitizer drugs for the U.S. market. But it says that as of the date of the letter, AG Hair hand sanitizer drug products continue to be listed with FDA, and shipments of products have entered the U.S. even after the company communicated its decision to stop manufacturing them.

“In response to this letter,” FDA writes, “clarify whether you intend to cease manufacturing and distribution of your hand sanitizer drug products in the United States. If your intent is to cease manufacturing and distribution of these products, delist all hand sanitizer drug products previously listed with FDA.”

The letter says FDA believes that based on the nature of the violations, the company should engage a qualified consultant to perform a comprehensive audit of its entire operation for CGMP compliance, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of the firm’s corrective and preventive actions before AG Hair pursues resolution of its compliance status with FDA.

FDA placed the firm on an Import Alert on 10/28.

AG Hair was told to promptly correct any violations and to reply with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.