The US Food and Drug Administration (USFDA) has issued a warning letter to Dabur India citing significant violations of current good manufacturing practices (CGMP) at its pharmaceutical manufacturing facility in Silvassa. According to reports from Business Standard, 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. The USFDA issued the letter dated July 24, 2027, to Dabur India CEO Mohit Malhotra, highlighting serious compliance failures at the manufacturing facility. Import Alert 66-40 has been placed on all drugs and drug products from the Silvassa facility with effect from June 5, 2026, restricting their entry into the US market until corrective actions are implemented. The regulator has advised Dabur to appoint an independent CGMP consultant to conduct a comprehensive review of the plant's manufacturing systems and quality management processes.
The USFDA's investigation revealed significant data integrity lapses, inadequate quality oversight and deficient manufacturing controls at the Silvassa facility. As reported by Business Standard, the most serious finding involved a falsified equipment usage logbook for a manufacturing line, where the version provided by the company deliberately omitted several US-marketed over-the-counter products that were listed in the original logbook found later in the document room. The regulator also cited shortcomings in laboratory controls, stating that analytical records were incomplete and supporting test procedures for several batches of US-marketed drug products were unavailable. 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. The inspection additionally found inadequate microbiological documentation and poor record-keeping related to equipment usage.
The USFDA found that Dabur's cleaning validation programme for shared manufacturing equipment was inadequate and relied largely on visual inspection without scientifically established carryover limits or quantitative residue testing. According to Business Standard, 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. 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.
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. As reported by Business Standard, the USFDA 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 regulator specifically noted that the company's response failed to address the systemic nature of the quality and data integrity failures. Dabur has now submitted a revised response outlining corrective measures to address the deficiencies, including employee retraining and improved documentation practices.
Despite the regulatory action, Dabur's Silvassa plant continues to operate while the company works with the USFDA to address the observations. According to CNBC TV18, Dabur's Global CEO Mohit Malhotra stated that the Silvassa plant concerns only a small part of the facility related to private label products, which generates insignificant revenue for the company. The company has already shifted production of some parts to its Baddi facility and does not anticipate any significant disruption to operations or business performance. The company maintains that domestic products are not covered under the US FDA action and that the Silvassa facility continues to operate for the domestic market, with the warning letter having no financial or operational impact on the company's overall operations.
