March 13, 2025

The US Food and Drug Administration (FDA) has issued multiple warning letters addressing violations of current good manufacturing practice (cGMP) regulations, as well as non-compliance with investigational new drug (IND) application requirements. These warnings highlight significant regulatory lapses by pharmaceutical companies operating in both the United States and globally.

IND Approval Violations

The FDA recently issued a warning letter to a company for conducting clinical trials without submitting an IND application. Inspections conducted under the Bioresearch Monitoring (BiMo) Program revealed that the company had initiated clinical investigations without appropriate regulatory approval.

The company argued that its product, a commercially available dietary supplement, qualified for an IND exemption since its trials were designed to assess tolerability rather than treat a disease. However, the FDA determined that the product was intended for use as a drug in clinical trials and, therefore, required an IND submission. The agency also found that the corrective action plan lacked sufficient detail and deemed it inadequate.

cGMP Violations Among Drug Manufacturers

The FDA also sent warning letters to multiple drug manufacturers for failing to comply with cGMP requirements. Violations included:

  • Failure to establish adequate specifications and testing procedures to ensure the quality and purity of active pharmaceutical ingredients (APIs).
  • Lack of written procedures for cleaning manufacturing equipment, leading to ineffective quality system management.
  • Failure to conduct identity tests on incoming production materials and inadequate oversight by quality units.
  • Insufficient investigation of discrepancies, batch failures, and contamination incidents in production environments.
  • Deficiencies in validation of supplier test analyses and improper sterilization processes.

The FDA strongly recommended that these companies engage qualified consultants to assess their operations and ensure compliance with cGMP standards. These consultants should conduct comprehensive audits to evaluate the effectiveness of corrective and preventive actions (CAPAs).

Maven’s Role in Ensuring Regulatory Compliance

For pharmaceutical and medical device companies, compliance with FDA regulations is crucial to maintaining product quality and market access. Maven offers comprehensive regulatory and quality assurance solutions to help businesses navigate these complex requirements.

Our services include:

 Regulatory Compliance Consulting – Assistance with IND applications, BiMo compliance, and cGMP adherence.
 Quality System Audits – Thorough evaluations of manufacturing processes, supplier qualification, and corrective action plans.
 Risk Assessments – Expert toxicology risk assessments for APIs, excipients, and finished products.
Training and Development – Guidance for quality units and executive management on regulatory expectations and best practices.

Conclusion

Failure to comply with cGMP regulations and IND requirements can result in serious regulatory consequences, including warning letters, product recalls, and market restrictions. Companies must take proactive steps to strengthen quality systems and regulatory compliance.

Maven provides expert guidance to help businesses mitigate regulatory risks and maintain compliance with FDA standards. Contact us today to ensure your operations meet industry best practices.