Dabur Faces USFDA Warning Letter Over Falsified Records, CGMP Violations at Silvassa Facility

The warning letter follows an inspection conducted by the US health regulator at the company's facility in Silvassa, Dadra and Nagar Haveli and Daman and Diu, from January to December 16, 2026.

USDFA, in its letter dated July 24, 2027, to Dabur India CEO Mohit Malhotra, has pointed out data integrity lapses, inadequate quality oversight and deficient manufacturing controls.

According to the USFDA, the facility's methods, controls and manufacturing practices did not conform to CGMP requirements, resulting in the products being considered "adulterated" under the US Federal Food, Drug and Cosmetic Act.

Among the most serious findings, the USFDA said its investigator discovered that an equipment usage logbook provided by the company for a manufacturing line was falsified, with the version handed over deliberately omitting several US-marketed over-the-counter products that were listed in the original logbook found later in the document room.

The regulator also observed that Dabur had not carried out process validation for a majority of the OTC drug products manufactured at the facility, raising concerns over the ability of the manufacturing processes to consistently produce products meeting quality standards.

While Dabur responded to the USFDA's observations, acknowledging lapses and committing to corrective measures including retraining staff, revising documentation practices and enhancing its cleaning validation programme, the regulator termed the response "inadequate" on all counts, saying it failed to address the systemic nature of the quality and data integrity failures.

The USFDA said it held a teleconference with the company on May 13, 2026, recommending removal of certain batches from the US market. Dabur subsequently issued a voluntary recall of some products on June 2, 2026, though the regulator noted the company had not recalled all affected drug products.

The USFDA placed all drugs and drug products from the Silvassa facility under Import Alert 66-40 with effect from June 5, 2026, and recommended the company engage an independent CGMP consultant to conduct a comprehensive audit of its operations.

"This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices."

"If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion," the letter said.