Ajanta Pharma said the United States Food and Drug Administration (USFDA) has completed an inspection at its Paithan manufacturing facility in Maharashtra, conducted between 13 April and 21 April 2026 ...

Rentschler Biopharma, a German CDMO, was cited by the FDA with a Form 483 following an inspection that revealed nine observations focused on procedural gaps and records keeping. FDA inspectors visited ...

The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...

Lupin has big plans to build market share in the U.S., but those plans were stymied when the FDA cited a facility in Goa from which it expects to ship new products. The head of the Indian drugmaker is ...

USFDA issues Form 483 with five observations to Ajanta Pharma's Paithan facility in Maharashtra after inspection. Company to ...

Having noticed an uptick in medical device recalls and FDA warning letters to medtech companies this year, it seems an appropriate time to look back on a Form 483 from December 2016 that surprised ...

The US Food and Drug Administration (FDA) on Friday released a Form 483 issued 18 August to blood testing startup Theranos, citing the company for allowing patients to consent to sample collection in ...

Just days since FDA, EMA and Health Canada announced that a second impurity, called N-nitrosodiethylamine (NDEA), has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals and FDA ...

Lupin receives USFDA Form 483 with three observations after inspection of its New Jersey facility, says it will address ...

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