Lachman Consultants' Team Teaches Young Professionals How Properly Preparing for and Addressing FDA Form 483 Ultimately Helps Save Patient's Lives. Wednesday, November 13, 2019 General News.

The FDA published the Form 483 on its website ... found these inappropriate changes were made as a quick fix instead of addressing frequent maintenance issues,” the FDA explained in the Form 483.

WESTBURY, N.Y., Nov. 12, 2019 /PRNewswire-PRWeb/ -- As a leading provider of expert compliance, regulatory affairs and technical services to life ...

Aurobindo's subsidiary Aurolife Pharma received a Form 483 from the FDA outlining 11 observations at a U.S. production plant, the Indian drugmaker said in a filing late last week.

Summary. I am downgrading Capricor Therapeutics, Inc. stock from Strong Buy to Hold due to FDA Form 483 risks from a Pre-License Inspection of its manufacturing facility.

In the firm’s written response to the FDA 483, dated Jan. 12, 2023, they explained that they will be following a new SOP for testing sprouts grown at their facility.

The company said the letter from the Food and Drug Administration (FDA) noted "deficiencies in the response" from DexCom to the FDA's Form 483, which outlines observations from investigators.. The ...

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 ...