The US FDA’s objection comes at a time when Indian drug and health care product manufacturers are facing increasing scrutiny from US regulators over quality standards and manufacturing practices.
According to the US FDA’s inspection report, the regulator identified several deficiencies at Dabur’s manufacturing plant, raising concerns over potential microbial impurities and non-compliance with manufacturing standards.
The investigating agency found deficiencies in equipment cleaning, maintenance and quality control procedures at the plant. Additionally, it also alleged that certain manufacturing data was manipulated to conceal the use of devices that were being used for products other than their intended purposes.
FDA inspectors found a live bird and bird droppings in a raw material warehouse located near packaging materials, the report said. Inspectors also observed an unidentified black substance on large portions of ceiling surfaces in raw material and finished product storage areas.
The FDA also expressed concern over the reliability of microbiological testing conducted at the plant. Although official data reportedly showed that the samples were within prescribed safety limits, inspectors found inaccuracies in several samples during the inspection process.
The report also said that the company’s management did not properly review production and quality records before starting to supply the goods to the market, potentially resulting in lapses in regulatory compliance.
Dabur India, one of the country’s oldest consumer goods companies and a leading supplier of ayurvedic and over-the-counter health products in the US market, has not issued any statement on the FDA’s comments.
Companies issued Form 483 by the FDA typically are required to submit a corrective action plan to correct deficiencies found during an inspection.
In Mann Ki Baat, PM Modi praised the achievements of Gurinderveer and Animesh, gave special congratulations!
Comments are closed.