FDA inspection documents reveal systemic contamination issues at ByHeart formula plant as botulism outbreak sickens 37 ...
The Food and Drug Administration "inadvertently archived" a whistleblower's complaint regarding conditions at an Abbott Nutrition plant that produced powdered baby formula recalled in 2022 due to ...
The FDA has released documents showing that unsanitary conditions at a production plant for ByHeart infant formula and positive tests for pathogens have ...
After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...
The Food and Drug Administration (FDA) has reported that BRS Analytical Services is recalling nearly 76,000 types of eye products. The FDA issued this massive recall after an audit revealed several ...
Reassessing Drug Inspection Targets: FDA Updates Internal Policy for Risk-Based Site Selection Model
In a continuing effort to improve the quality system effectiveness of human drug manufacturing sites, FDA revised MAPP 5014.1, Understanding CDER’s Risk-Based Site Selection Model (Site Selection MAPP ...
FDA inspections cause fear among some and apprehension amongst others. Such inspections often result in a disruption of activities and may result in a negative action taken by the federal government.
After a pandemic-fueled lull the past few years, FDA inspections are back in full force. This week, a pair of Indian drugmakers have found themselves in the agency’s crosshairs. The FDA has handed ...
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US FDA Inspection on Rise: Indian Pharma and Medical Devices Manufacturers Strengthen GMP Compliance
City, India, December 23, 2024: In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device manufacturers are enhancing their Good ...
The FDA hit Eugia, a unit of Indian drugmaker Aurobindo, with a classification of “Official Action Indicated” in the wake of a plant inspection at its Bhiwadi Unit II facility in April and May. The ...
In the past, FDA handled all inspections of manufacturing facilities. However, as U.S. manufacturers began to expand nationally and globally, the rising rate made it difficult for the limited number ...
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