The U.S. Food and Drug Administration (USFDA) has issued a warning letter to Dabur India, a leading FMCG company, after finding serious violations of current good manufacturing practices (CGMP) at its pharmaceutical plant in Silvassa. The letter highlights lapses in data integrity, quality oversight and manufacturing controls that could jeopardise product safety.
The warning follows an inspection carried out by the US regulator between January and December 16, 2026, at the Silvassa facility located in Dadra and Nagar Haveli and Daman and Diu. The inspection covered all aspects of the plant’s operations and documentation.
USFDA’s letter, dated July 24, 2027, points out that the facility’s methods, controls and manufacturing practices did not meet CGMP requirements. As a result, the regulator considered the products to be “adulterated” under the U.S. Federal Food, Drug and Cosmetic Act.
One of the most serious findings was that an equipment usage logbook for a manufacturing line was falsified. The logbook handed to the regulator omitted several U.S.-marketed over‑the‑counter products that were present in the original version found in the document room.
Lab controls were also found to be inadequate. Analytical records were incomplete and key test procedures, workbooks and data sheets for several batches were missing. Microbiological testing records were deficient and equipment usage was not properly documented.
The cleaning validation programme for shared equipment was found lacking. It relied mainly on visual inspection and did not use scientifically established carry‑over limits or quantitative residue testing.
USFDA also noted that Dabur had not performed process validation for most OTC drug products at the Silvassa plant. This raises doubts about whether the manufacturing processes can consistently produce products that meet quality standards.
Dabur responded to the letter, acknowledging the lapses and promising corrective actions such as retraining staff, revising documentation and improving cleaning validation. However, the regulator called the response inadequate and said it did not address the systemic nature of the failures.
The regulator held a teleconference with Dabur on May 13, 2026, and recommended removal of certain batches from the U.S. market. In response, Dabur issued a voluntary recall of some products on June 2, 2026, but the regulator noted that not all affected products were recalled.
From June 5, 2026, all drugs from the Silvassa facility are under Import Alert 66‑40. The USFDA also advised the company to engage an independent CGMP consultant for a comprehensive audit of its operations.
The letter gives Dabur 15 working days to submit a written response detailing corrective actions and a schedule for completion. If the company cannot finish the actions within the deadline, it must explain the delay and provide a new timeline.