Dabur downplays USFDA warning, says India business unaffected; Silvassa plant continues operations

Dabur India on Thursday said its domestic business remains unaffected despite receiving a warning letter from the US Food and Drug Administration (USFDA) over manufacturing deficiencies at its pharmaceutical facility in Silvassa. The company also confirmed that the plant continues to operate while it works with the regulator to address the observations.

The FMCG major said it has submitted a revised response to the USFDA outlining corrective measures to resolve the issues identified during the inspection.

"The Silvassa plant continues to be operational. This order concerns only a small part of our plant in relation to private label, which generates insignificant revenue for the company. Moreover, production of some part has already been shifted to our Baddi facility, and we do not anticipate any significant disruption to operations or business performance," Dabur’s Global CEO Mohit Malhotra said.

The USFDA issued the warning letter after identifying significant violations of Current Good Manufacturing Practices (CGMP) at the company's pharmaceutical manufacturing unit in Silvassa. The action follows an inspection carried out at the facility between January and 16 December 2026.

In its letter dated 24 July 2027, addressed to Malhotra, the regulator cited multiple deficiencies, including data integrity concerns, inadequate quality management and shortcomings in manufacturing controls.

According to the USFDA, the manufacturing methods, controls and operating procedures at the facility failed to meet CGMP standards, resulting in products being classified as "adulterated" under the US Federal Food, Drug and Cosmetic Act.

Among the major observations, the regulator alleged that an equipment usage logbook submitted during the inspection had been falsified. It said the version initially provided excluded several over-the-counter (OTC) products marketed in the United States, which were later found in the original records stored in the document room.

Deficiencies in lab practices flagged

The USFDA also flagged deficiencies in laboratory practices, stating that analytical records were incomplete and that key testing procedures, workbooks and supporting data for several batches of US-bound drug products were unavailable. It further noted inadequate microbiological documentation and poor record-keeping related to equipment usage.

The inspection additionally found weaknesses in Dabur's cleaning validation programme for shared manufacturing equipment. According to the regulator, the company relied largely on visual inspections instead of scientifically established residue limits and quantitative testing to verify equipment cleanliness.

Another key concern raised by the USFDA was the absence of process validation for a majority of the OTC medicines produced at the Silvasa facility, raising questions about the consistency of product quality.

While Dabur acknowledged certain shortcomings and proposed corrective actions, including employee retraining, improved documentation practices and enhancements to its cleaning validation programme, the USFDA described the company's initial response as inadequate. The regulator said the proposed measures did not sufficiently address the broader systemic issues involving quality assurance and data integrity.

The USFDA also disclosed that it held a teleconference with Dabur on May 13, 2026, during which it recommended the withdrawal of certain product batches from the US market. The company subsequently initiated a voluntary recall of selected products on June 2, 2026. However, the regulator noted that not all affected products had been recalled.

Effective June 5, 2026, the USFDA placed all drugs and pharmaceutical products manufactured at the Silvasa facility under Import Alert 66-40. It also advised Dabur to appoint an independent CGMP consultant to conduct a comprehensive review of the plant's manufacturing systems and quality management processes.

"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.