USFDA Issues Warning Letter To Dabur Over Data Integrity, Manufacturing Lapses At Silvassa Plant

The US Food and Drug Administration (USFDA) has issued a warning letter to Dabur India over serious manufacturing and quality control lapses at its pharmaceutical facility in Silvassa, raising concerns over compliance with current good manufacturing practices (CGMP).

According to a report by Business Standard, the warning follows an inspection conducted by the US health regulator at the company’s manufacturing unit in Silvassa, Dadra and Nagar Haveli and Daman and Diu.

The USFDA said the facility failed to meet required standards under the US Federal Food, Drug and Cosmetic Act, making products manufactured there liable to be considered “adulterated”.

Quality Control Issues

In its communication to Dabur India CEO Mohit Malhotra, the regulator highlighted several violations, including data integrity failures, inadequate quality oversight and deficiencies in manufacturing controls.

One of the major findings involved alleged falsification of an equipment usage logbook. The USFDA said a document submitted by the company for a manufacturing line had intentionally excluded details of multiple over-the-counter products sold in the US.

The original records containing the missing information were later found in the facility’s document room.

The regulator also pointed out deficiencies in laboratory operations, stating that analytical records were incomplete and supporting documentation, including test procedures, workbooks and data sheets for certain batches, was unavailable. Issues were also identified in microbiological testing records and equipment documentation.

Dabur Asked To Strengthen Compliance

The USFDA further criticised Dabur’s cleaning validation process for shared manufacturing equipment, saying it relied mainly on visual checks without scientifically established residue limits and adequate testing procedures.

The regulator also noted that process validation had not been completed for several OTC products manufactured at the facility.

Dabur responded to the observations by committing to corrective steps, including employee retraining, improved documentation practices and strengthening cleaning validation systems. However, the USFDA termed the response inadequate, stating that it did not sufficiently address the broader systemic issues.