FiercePharma

FDA follows Form 483 to Indian drugmaker Laurus Synthesis with a 2nd rebuke

The FDA, which issued India’s Laurus Synthesis a Form 483 in January, followed up the action with an "untitled letter" (PDF) that outlined the Indian drugmaker’s problems with its quality control unit ...
MD&M East

That Time FDA was ‘Unusually Thorough’ on a Form 483

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 ...
FiercePharma

FDA slams 3 Indian drugmakers in flurry of recent Form 483s

The FDA slammed three Indian drugmakers with Form 483s following recent inspections that uncovered unsanitary conditions, broken equipment and poor recordkeeping. Mumbai-based Alkem Labs was cited ...
RAPS

FDA Sends Form 483 to Sterile Manufacturer Akorn Pharmaceuticals’ Illinois Plant

The US Food and Drug Administration (FDA) on Tuesday released a Form 483 (which can be the precursor to a warning letter) with six observations to one of two Akorn Pharmaceuticals’ Decatur, ...
RAPS

FDA Form 483: Theranos Initiated Trials Without IRB Approval

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 ...
MD&M East

Responding to FDA Form 483 and Warning Letters: Dos and Don’ts

There is a scene in the old Rodney Dangerfield movie Back to School in which Dangerfield’s character, Thornton Melon, is preparing to take an oral exam from all his professors. One particularly stern ...
Hosted on MSN

Lupins Goa facility inspected by U.S. FDA; form-483 issued with seven observations

Mumbai, Nov. 22 -- The inspection concluded with a Form-483, citing seven observations. Lupin stated that it will address the observations and respond to the FDA within the stipulated timeframe, and ...
Hosted on MSN

Piramal Pharma shares in focus after USFDA issues Form 483 for Kentucky unit

Shares of Piramal Pharma are set to be in focus on Friday, December 12 after the US Food and Drug Administration concluded a general Good Manufacturing Practices inspection at the company’s Lexington ...