FDA issues Warning Letter due to GMP Violations at Chinese Drug Manufacturer

On 25 February 2025, the United States Food and Drug Administration (FDA) issued a Warning Letter to a Chinese company due to significant violations of Current Good Manufacturing Practice (CGMP) regulations. This was based on a review of records submitted in response to an official request for records and other information.

The facility is registered as a manufacturer of over-the-counter (OTC) drug products, including anti-microbial wipes.

Key Violations

Based on the review of documentation provided by the company, the FDA identified three major issues:

• Inadequate Component Testing (21 CFR 211.84(d)(1) and (d)(2)): The company failed to perform appropriate identity and purity testing of raw materials used in the manufacturing of OTC drug products. Specifically, the firm neglected to test ethanol for methanol contamination, which is essential to prevent lethal poisoning incidents. Furthermore, glycerin was not adequately tested for toxic impurities such as diethylene glycol (DEG) and ethylene glycol (EG).
• Inadequate Stability Testing Program (21 CFR 211.166(a)): The firm did not establish a proper stability testing program for its anti-microbial wipes, failing to scientifically justify labeled expiration dates and storage conditions. For example, the firm conducted stability studies under “accelerated aging experiments” without scientific justification. In addition, the company did not perform stability studies under long-term storage conditions.
• Insufficient Quality Control Unit (21 CFR 211.22(a)): The FDA identified significant deficiencies within the company's quality control unit (QU). Specifically, the QU lacked appropriate authority and oversight capabilities necessary to ensure compliance with CGMP requirements.

Consequences and Required Actions

Due to these violations, the FDA placed the company's drug products on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs") as of 10 February 2025.

The FDA requests that the company submit a written response detailing corrective measures within 15 working days. If the firm cannot resolve the issues within this period, it must provide a clear timeline for the corrections. Compliance verification may involve future FDA inspections.

The complete Warning Letter to Linghai ZhanWang Biotechnology Co., Ltd was published on the FDA's website.