API manufacturer Global Calcium has been struck with a Form 483 filing following an FDA inspection of its factory in India. Between 29 July and 2 August 2024, the agency inspected Global Calcium ...

While for many Indian drugmakers, a Form 483 has been simply a prelude to an ... had eight observations for the plant, which makes a number of statin APIs as well as insulin.

Cook Pharmica, a biologics manufacturing company Catalent bought last year, was hit with a Form 483 by the FDA following an inspection that uncovered problems with a high number of mold ...

Form 483 is generally the first indication of trouble ... Over the past four years, India received the highest number of warning letters issued to a single country. Also, the number of warning ...

The inspection concluded with a Form 483 containing several observations. Capricor said it has submitted its responses to the FDA, none of which required material changes to the cGMP process or ...

However, the newest list, which spans the timeframe from Oct. 1, 2014, to Sept. 30, 2015, has a common theme. The number one reason for Form 483 observations is “Procedures not in writing or not fully ...

Regulators’ Form 483 from an inspection of the Bayview plant in Baltimore ... Real world U.K. data show only small number of COVID-19 vaccine failures LONDON – The latest tranche of data from an array ...

Torrent Pharmaceuticals on Friday said the US health regulator has issued a Form 483 with one observation after inspecting its Pithampur-based manufacturing facility. The US Food & Drug ...

On Thursday, Dr. Reddy's Laboratories, a prominent pharmaceutical company, disclosed to the stock exchanges that it has been issued a Form 483 containing nine observations by the US Food & Drug ...