Last Updated on December 22, 2024 by The Health Master
Warning letter
U.S. Food and Drug Administration (USFDA) issues Warning Letter to Global Cosmetics (China) Company Limited for CGMP Violations in Hand Sanitizer Manufacturing.
Serious Manufacturing Issues Identified in OTC Drug Production
The U.S. Food and Drug Administration (USFDA) has issued a warning letter to Global Cosmetics (China) Company Limited citing significant violations of Current Good Manufacturing Practice (CGMP) regulations for over-the-counter (OTC) drugs, specifically hand sanitizer.
Key Violations:
Lack of Identity Testing:
The company failed to properly test incoming materials used in hand sanitizer production, including crucial verification of the active ingredient, ethanol, for methanol contamination.
Methanol is a toxic alcohol that can cause serious health problems, including blindness and death.
Inadequate Stability Testing:
The stability testing program for hand sanitizers was insufficient.
Stability testing ensures that a drug product remains safe and effective throughout its shelf life.
The company only provided data for 12 weeks, and proper chemical and microbiological testing wasn’t demonstrated.
Ineffective Quality Control Unit:
The quality control unit (QU) wasn’t functioning effectively to oversee the quality of manufacturing operations.
The QU is responsible for approving or rejecting materials, drug products, and packaging.
Potential Health Risks and Consumer Impact
These violations raise concerns about the quality, safety, and efficacy of Global Cosmetics’ hand sanitizers.
Without proper testing and quality control, consumers could be exposed to contaminated or ineffective products.
USFDA Recommendations and Next Steps
The USFDA recommends that Global Cosmetics:
- Engage a qualified CGMP consultant to assess their entire operation and implement corrective actions.
- Take steps to ensure proper identity testing of all components, including testing ethanol for methanol contamination.
- Develop an adequate stability testing program with appropriate testing parameters and durations.
- Strengthen the quality control unit to effectively oversee manufacturing processes.
The USFDA has placed Global Cosmetics on Import Alert 66-40, which could restrict entry of their products into the United States.
The company has 15 business days to respond to the USFDA outlining their corrective action plan.
Failure to address the violations promptly could lead to further enforcement actions, including product seizure or import refusal.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
To read the original contents of the warning letter, click here.
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