The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant ...

WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the ...

When the primary use of a product is an unlabeled use -- an indication not listed in the FDA-approved labeling -- it can be especially difficult to get information about a shortage. Manufacturing ...

The observations were issued on Friday after the US drugs watchdog wrapped up its inspection of the Eugia facility, Unit-III, that is located on the outskirts of Hyderabad. The inspection was ...

A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable." Dexcom manufactures its products at its headquarters in San Diego, California and at ...

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections of the company’s facilities in San Diego ...

New Delhi Emcure Pharmaceuticals on Wednesday said the US health regulator has issued two observations after inspecting its Pune-based active pharmaceutical ingredients (API) manufacturing facility.

The company is confident of addressing these observations expeditiously and will respond to the FDA with a corrective and preventive action plan (CAPA) in a timely manner, the spokesperson said.