The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant ...
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 its ...
In preparing that report, AMA held discussions with FDA, the Pharmaceutical Re-search and Manufacturers of America, and ASHP. Among the report's recommendations was to ask the secretary of the ...
FDA inspectors visited Dexcom’s facility in Mesa, Arizona, in June and its San Diego site in October and November. The inspections generated a Form 483 that listed observations the FDA made ...
It has not indicated any further escalation, Granules said. Significant progress has been made to address all of the FDA observations across the four areas with most corrective actions completed ...
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.
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 ...
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 ...
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 ...
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