The US Food and Drug Administration (FDA) has highlighted serious manufacturing, maintenance, and data integrity issues at a Dabur India manufacturing plant in Dadra and Nagar Haveli. The FDA inspection report revealed various deficiencies at the facility, including concerns about potential microbiological contamination and failure to comply with manufacturing standards. Equipment cleaning, maintenance, and quality control procedures were found lacking, with allegations of falsified manufacturing records to conceal equipment use for unauthorized products.
FDA inspectors discovered a live bird and bird droppings in a raw material warehouse near packaging materials at the plant. Additionally, they noted an unidentified black substance on ceiling surfaces in raw material and finished product storage areas. The FDA expressed doubts about the accuracy of microbiological testing conducted at the facility, citing discrepancies between official safety limit reports and actual contamination levels found during inspections.
The report also criticized the company’s management for inadequate review of production and quality records before releasing batches to the market, potentially jeopardizing regulatory compliance. Dabur India, a prominent consumer goods company and a key supplier of Ayurvedic and over-the-counter healthcare products in the US, has not responded to requests for comment on the FDA’s observations. Companies receiving an FDA Form 483 are typically required to submit corrective action plans to address identified deficiencies.
