Significant Update

The US Food and Drug Administration (FDA) has raised serious compliance concerns at Dabur India‘s over-the-counter (OTC) manufacturing facility in Dadra and Nagar Haveli following an inspection conducted between January 12 and January 16, 2026. In a Form 483 inspection report, the regulator cited alleged documentation irregularities, data integrity concerns, questionable microbiology testing practices, sanitation deficiencies, and potential contamination risks that could affect product quality and safety.

FDA Questions Equipment Usage Records

The FDA alleged that Dabur created revised equipment usage records between April 2024 and December 2025 that removed references to several US OTC products manufactured using the same equipment. According to the regulator, these revised logs contradicted the company’s earlier claims that the equipment was dedicated exclusively to specific product lines. The FDA stated that documentation practices that exclude recorded product usage information fail to ensure complete and accurate equipment records.

Regulator Raises Concerns Over Laboratory Controls

The inspection also revealed concerns about the reliability of microbiological testing conducted at the Dabur facility. The FDA noted that several finished-product microbiology records reviewed during the inspection reported results of “<10” or zero microbial colonies, despite investigators allegedly observing visible microbial growth during plate-reading activities, including samples classified as “too numerous to count” (TNTC).

The regulator further identified repetitive numerical patterns in duplicate microbial testing data, which it said could indicate that the results did not reflect actual analytical findings. Beyond the concerns over reported test results, investigators also found gaps in laboratory record-keeping. Several microbiology testing plates referenced in analytical notebooks were missing during the inspection, and the company could not provide documentation explaining their disposal or whereabouts.

The FDA further alleged that the facility’s quality control unit failed to investigate the absence of microbiological out-of-specification results over the past five years and did not establish adequate analytical controls.

Cleaning Validation Gaps May Increase Contamination Risk

The FDA also identified deficiencies in cleaning validation procedures for non-dedicated manufacturing lines used across multiple OTC products. According to the inspection report, the facility relied largely on visual inspection standards without establishing scientifically justified limits for product carryover or microbiological cleanliness.

The regulator warned that inadequate cleaning validation, coupled with the alleged misrepresentation of equipment usage, could increase the risk of cross-contamination in OTC products that remain in distribution or within their expiry period.

Inspectors’ Note Sanitation Deficiencies

In addition to manufacturing and testing concerns, FDA inspectors observed sanitation-related deficiencies at the facility. These included the presence of a live bird and bird droppings in a raw material warehouse located near packaging materials, unidentified black substances on sections of warehouse ceiling surfaces, and gaps in warehouse dock doors. The regulator indicated that such conditions could compromise the facility’s ability to maintain appropriate manufacturing and storage environments.

Form 483 Requires Corrective Action

The FDA issued the observations through a Form 483, a document provided at the conclusion of an inspection when investigators identify conditions that may violate US manufacturing regulations. A Form 483 does not represent a final regulatory determination or enforcement action. However, companies typically must investigate the observations and submit corrective and preventive action plans to address the identified concerns.

Source: Money Control 

The Hindu