The US Food and Drug Administration (FDA) has issued a nine-observation Form 483 to Dabur India Limited following an inspection of its over-the-counter (OTC) drug manufacturing plant in Dadra and Nagar Haveli, India, conducted between 12-16th January 2026.
The findings, which were made public on 26th May, document extensive current good manufacturing practice (CGMP) violations spanning data integrity, facility sanitation, equipment cleaning validation and batch record management.
Data integrity failures and falsified records
Among the most serious findings, the FDA investigator observed that 100% of microbiology test results for finished products were recorded as showing zero colonies, despite the inspector personally observing microbial growth.
This included two plates rated as too numerous to count (TNTC) during the inspection.
Repeated numerical patterns in replicate test results further suggest that the data does not reflect genuine analytical outcomes.
The 483 also details the deliberate falsification of equipment usage logs. Records covering April 2024 to December 2025 were rewritten to conceal that equipment claimed to be dedicated to a single product line had, in fact, been used to manufacture multiple US-marketed OTC products.
The FDA described this as a direct contradiction of contemporaneous record-keeping principles.
Cleaning validation and cross-contamination risk
One production line, which had been falsely represented as dedicated to a single product, was used for multi-product manufacturing with no cleaning validation — a finding the FDA said affects more than a defined number of OTC batches still within expiry.
Elsewhere in the facility, cleaning validation relied exclusively on visual inspection, with no quantitative residue limits, parts-per-million criteria or microbiological standards established.
Direct surface sampling of equipment contact surfaces and hard-to-clean areas was not performed.
Batch release without QC review
The Form 483 also detailed how batch manufacturing and analytical records were not reviewed and approved by the quality control unit prior to product release.
Discrepancies were identified across multiple products, including mismatched test values between batch manufacturing records and analytical notebooks, an incorrectly documented active pharmaceutical ingredient quantity and swapped assay values between a third-party certificate of analysis and the firm's own.
Despite this, Dabur did not initiate an investigation.
Facility conditions
A live bird, as well as bird droppings, were found in the raw material warehouse, approximately 30 feet from packaging materials, while an unidentified black substance covered more than 25% of the ceiling surfaces in both the raw material and finished drug product storage warehouses.
A gap in a dock door was also noted as a potential pest entry point.
Stagnant liquid found in production hoses posed additional microbiological contamination risks and annual product quality reviews had not been conducted for the majority of products manufactured at the site. This violated the firm's own SOPs.
The findings come as Indian pharmaceutical manufacturers face continued regulatory scrutiny from the FDA around quality standards for products exported to the United States.
Dabur — one of India's largest consumer goods companies and a major supplier of OTC health products — had not responded publicly to the inspection findings at the time of publication.
Companies typically respond to a Form 483 with a corrective action plan; though, a Warning Letter may follow if the FDA deems the response inadequate.
Dabur India was contacted for comment.