FDA Warning Letter: Potential Contaminant Risks and Quality Control Failures at OTC Drug Manufacturer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a U.S. drug manufacturer. The document, dated 17 July 2024, was published on 19 September 2024 and refers to an inspection performed in January 2024. The letter highlights multiple critical violations of Current Good Manufacturing Practice (CGMP) regulations, particularly regarding production and quality control.

Raw Materials Testing

The company failed to adequately test incoming raw materials used in drug production, including active pharmaceutical ingredients (API) and other high-risk components. According to the FDA, the firm “released API and other materials for use in drug product manufacturing based on your supplier’s certificate of analysis (COA) without performing at least one specific identity test on each component." This is especially crucial for substances prone to contamination, like glycerin and sorbitol, which could be adulterated with diethylene glycol (DEG) or ethylene glycol (EG), both toxic compounds that can cause poisoning, organ failure, or death when ingested.

Water

The firm produced water used as a component in its drug products but lacked data demonstrating its suitability for manufacturing aqueous-based OTC drug products. The FDA concludes that the lack of control data for the water system poses a potential risk of introducing objectionable microbial contamination.

Quality Unit (QU)

The company lacks an adequate quality unit to ensure product safety, quality, and regulatory compliance. The absence of an effective quality control system raises concerns about the consistent production of safe, compliant products.

Corrective Actions

The FDA has requested the company to take immediate corrective actions, including:

• Conducting a comprehensive evaluation of quality systems and manufacturing processes.
• Developing a risk assessment for the use of raw materials, including high-risk components.
• Implementing a robust testing program for raw materials and finished products to ensure CGMP compliance.

The letter closes with a warning that failure to address the cited violations could lead to legal action, including product seizures and injunctions. The company must submit a detailed response within 15 working days.

For full details, you can view the letter on the FDA’s website.