The U.S. Food and Drug Administration (USFDA) has issued a warning letter to the major Indian Fast-Moving Consumer Goods (FMCG) manufacturer Dabur India, citing serious violations of Good Manufacturing Practices (CGMP) at the company's pharmaceutical manufacturing facility in Silvassa.
This letter followed an inspection conducted by the U.S. health regulator at the Dabur facility in Silvassa, as well as in the regions of Dadra and Nagar Haveli and Madhva and Diu, which took place from January to December 2026. In a letter dated July 24, 2027, addressed to Dabur India's CEO Mohit Malhotra, the USFDA highlighted issues with data integrity, inadequate quality control, and improper manufacturing procedures.
According to the USFDA, the facility's methods, controls, and manufacturing practices did not comply with CGMP requirements, leading to products being deemed 'adulterated' under the U.S. Federal Food, Drug, and Cosmetic Act. Among the most serious findings, the USFDA investigator determined that the equipment usage log provided by the company for the production line was falsified, as the version submitted to the inspector intentionally omitted certain over-the-counter products sold in the U.S. that were present in the original log found later in the documentation department.
The regulator also noted deficiencies in laboratory control, stating that analytical records were incomplete, and working notebooks and data sheets confirming testing procedures for several batches of medicines intended for the U.S. market were missing. Furthermore, it was observed that microbiological test records were incomplete, and equipment usage was not properly documented.
Moreover, the USFDA discovered that the cleaning validation program for the company's shared production equipment was insufficient and relied heavily on visual inspection, lacking scientifically sound cross-contamination limits or quantitative residue testing. The regulator also noted that Dabur did not conduct process validation for most over-the-counter products manufactured at this site, raising concerns about the ability of the manufacturing processes to consistently ensure product quality.
Although Dabur responded to the USFDA's observations, acknowledging shortcomings and promising corrective actions, including staff retraining, revision of documentation practices, and improvement of the cleaning validation program, the regulator deemed this response 'inadequate' across the board because it failed to address the systemic nature of the quality and data integrity problems.
The USFDA reported holding a teleconference with the company on May 13, 2026, recommending the withdrawal of certain batches from the U.S. market. Subsequently, Dabur voluntarily recalled some products on June 2, 2026, although the regulator noted that the company had not recalled all affected medicines. The USFDA placed all Dabur medicines and products from the Silvassa plant on import alert list 66-40 starting June 5, 2026, and advised the company to engage an independent CGMP consultant to conduct a comprehensive audit of its operations.
The letter stated: 'This letter notifies you of our findings and provides you with an opportunity to correct the aforementioned deficiencies. Upon receipt of this letter, you must respond to our office in writing within 15 business days, detailing what you have done to remedy any violations and prevent their recurrence. In response to this letter, you may provide additional information for our review while we continue to assess your operations and practices.' The letter also mentioned: 'If you are unable to implement corrective actions within 15 business days, state the reasons for the delay and your completion schedule.'
