The U.S. Food and Drug Administration (FDA) has taken regulatory action against two parties for significant compliance lapses—Hikal Limited, an Indian drug manufacturer, and Shirish Gadgeel, MD, a clinical investigator at Henry Ford Hospital in Michigan. These cases highlight the importance of rigorous oversight in both drug manufacturing and clinical research to protect patients and ensure product quality.
Hikal Limited: Manufacturing Quality Deficiencies
Hikal Limited was cited for multiple violations of current Good Manufacturing Practices (cGMP). According to FDA, the company’s quality unit failed to adequately investigate and resolve complaints related to metal contamination in active pharmaceutical ingredients (APIs). Between 2020 and 2025, the firm received 22 contamination complaints, yet its investigations did not provide sufficient evidence that the particles were inherent to the manufacturing process.
The FDA further noted that Hikal’s corrective and preventive action (CAPA) plans were ineffective, as contamination persisted even after investigations were closed. Additionally, the company lacked a robust system for re-evaluating critical suppliers, continuing to source defective materials despite repeated complaints. These findings raise serious concerns about supplier oversight and product safety.
Clinical Trial Oversight: Failures in Informed Consent and Enrollment
In a separate case, FDA issued a warning letter to Dr. Shirish Gadgeel for good clinical practice (GCP) violations. Investigators determined that Dr. Gadgeel enrolled participants who did not meet eligibility requirements and failed to remove subjects who should have been withdrawn per the study protocol.
Equally concerning, FDA found that informed consent procedures were not properly followed. At least one participant did not receive the required separate consent for genetic testing. While corrective actions were proposed, the agency deemed them insufficient due to a lack of detailed mitigation strategies.
FDA emphasized that investigators bear ultimate responsibility for protecting participants and ensuring compliance with regulations. Deviations from protocol not only endanger trial participants but also compromise the integrity of study data used to evaluate investigational treatments.
Broader Implications for Industry
These warning letters illustrate the FDA’s ongoing commitment to enforcing high standards across the life sciences sector. For manufacturers, the Hikal case underscores the necessity of thorough complaint investigations, effective CAPA systems, and proactive supplier management. For clinical researchers, the Gadgeel case is a reminder that informed consent and strict adherence to trial protocols are non-negotiable responsibilities.
Both cases reinforce the message that lapses in quality systems or patient protections can have wide-reaching consequences, from regulatory delays to reputational damage.
Conclusion
As regulatory scrutiny continues to evolve, companies and clinical investigators must maintain robust compliance frameworks. Ensuring transparency, proper documentation, and effective corrective actions are key to avoiding enforcement actions and protecting patient safety.
At EMMA International, we support pharmaceutical and clinical research organizations in building and maintaining compliant systems that withstand regulatory inspection. From quality management to clinical trial oversight, our team provides tailored guidance to help organizations bring safe, effective, and reliable products to market.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
Regulatory Affairs Professionals Society. (2025, September 9). FDA warns Indian drugmaker over quality lapses, clinical researcher for enrollment issues. Retrieved from https://www.raps.org/news-and-articles/news-articles/2025/9/fda-warns-indian-drugmaker-over-quality-lapses
