Similasan Marketing Unapproved New Drugs: FDA

A 3/27-4/3 FDA inspection at the Similasan AG drug manufacturing facility in Jonen, Switzerland, determined that the firm is marketing several unapproved new ophthalmic drugs. A 9/11 Warning Letter identifies significant violations of current good manufacturing practice (CGMP) regulations in the production of the unapproved drugs. “Your unapproved ophthalmic drug products are especially concerning from a public health perspective, particularly given your firm’s significant violations of CGMP regulations,” the letter says. “Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.”

The letter lists 12 unapproved new drugs the company is manufacturing based on the FDA review of their labeling and the company’s Web site. It includes claims made for each of the drugs that indicate they are intended for use in the diagnosis, care, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

CGMP violations identified in the letter were:

• failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
• failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug products, containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
• failing to ensure that laboratory records include complete data derived from all tests necessary to ensure compliance with established specifications and standards; and
• failing to establish an adequate quality control unit and failing to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit.

FDA says that based on the nature of the violations it identified, Similasan should engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements if the firm intends to resume manufacturing drugs for the U.S. market. It says the consultant should perform a six-system audit of the company’s entire operation for CGMP compliance and evaluate the completion and efficacy of its corrective and preventive actions before the firm pursues resolution of its compliance status with FDA.

The agency also says the company manufactures drugs that contain glycerin and sorbitol solution and must meet CGMP requirements when manufacturing drugs containing ingredients that are at high risk for diethylene glycol or ethylene glycol contamination.

Similasan was told to correct any violations promptly and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with copies of related documentation and a schedule for completing the corrections.