Hikal Ltd. Receives Warning Letter from USFDA with Potential Financial Implications

Hikal Ltd. has disclosed receiving a Warning Letter from the United States Food and Drug Administration (USFDA) for their Bangalore site. The site was inspected in February 2025, resulting in six observations in Form 483. The USFDA classified the site with an ‘Official Action Intended’ status on May 2025 and issued a Warning Letter on August 21, 2025. The letter cited inadequate investigations of customer complaints on foreign matter and shortcomings in vendor management as reasons for issuance. The communication will be applicable until a reinspection of the facility by the USFDA. Hikal has responded to the Warning Letter with corrective actions, many of which have already been implemented.