U.S. FDA issues four observations to Gland Pharma formulation facility near Hyderabad
The four Form 483 observations followed an unannounced inspection on current good manufacturing practice at the facility in Dundigal between October 12 and 23
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The four Form 483 observations followed an unannounced inspection on current good manufacturing practice at the facility in Dundigal between October 12 and 23
The FDA said inspections uncovered unhygienic kitchens and drainage systems, rusted racks and utensils, returned bread being mixed with fresh bread, incomplete temperature records, employees without medical certificates and the use of unauthorised food colours in sweets
The FDA said the banned-product seizures in Mumbai and Jalna, including vehicles and other items, were valued at ₹93.42 lakh
The Food Safety Commissioner’s order bans prohibited colouring agents, including Metanil Yellow and Rhodamine B, and adulterants such as brick powder and chalk, and requires all spice powders to be packed and sealed at the place of production before sale
Olympus Corp. shares tumbled the most since April 2025 after the US Food and Drug Administration issued a warning letter to the Japanese medical device maker following inspections the agency previously conducted at six facilities.
Tukaram Mundhe said the FDA had begun inspecting milk collection centres across Maharashtra to check for adulteration, unsafe milk and compliance with prescribed practices
The case dates back to June 12, when FDA food safety officers in Pune inspected the establishment following a complaint of food poisonining
In the first operation, FDA teams seized banned gutkha, pan masala and scented tobacco along with two trucks, collectively valued at ₹1.26 crore, following interceptions in Palghar and Thane districts