Record spike in new coronavirus cases reported in six U.S. states as reopening accelerates

An employee complaint at Eli Lilly’s Branchburg plant alleges altered quality control docs amid …

… antibody bamlanivimab, after issuing a two-observation Form 483 in August that faulted the site for inadequate quality and laboratory controls.

Ins & outs: Emergent exec shake up following Bayview 483

However, production was halted at the facility in April after a US Food and Drug Administration (FDA) inspection resulted in a Form 483 with nine …

ICYMI: Week in review, April 26-30, 2021

Emergent Biosolutions Inc. CEO Robert Kramer assured investors that he takes “full responsibility” for woes that beset the firm after the FDA’s Form 483 …

FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities

This will replace the traditional issuance of Inspectional Observations Form FDA 483. These written observations are not a final agency action or …

Fixes to Bayview plant Emergent soon? FY21 guidance clipped

… FDA’s Form 483 found serious manufacturing problems at the Baltimore, Md.-based Bayview plant. “You have my commitment that we’re going to do …

FY21 guidance cut, Emergent outlines post-Form 483 with CDMO business

Regulators’ Form 483 from an inspection of the Bayview plant in Baltimore, Md., listed nine observations related to cross-contamination issues, lack of …

Emergent recognized cross contamination risk at Bayview plant hit with 483

… of the US Food and Drug Administration (FDA) after an inspection resulted in a Form 483 with nine observations. Image: iStock/Aliaksandr Bukatsich.

See Me, Feel Me: FDA Gives Guidance on Remote Interactive Evaluations of Drug Facilities During …

The agency will present a list of observations, but will not issue a Form FDA 483 (Inspectional Observations). A remote interactive evaluation is not …

COVID-19 Medical Products Supply Chain Week in Review – April 2021 #4

… completed its inspection of J&J’s Emergent vaccine contract manufacturing site in Baltimore and posted the Form FDA-483 with nine observations.

ComplianceOnine Hosts Seminar on Change Control Best Practices for Pharmaceutical, Biologics …

One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA …

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New coronavirus infections hit record highs in six U.S. states on Tuesday, marking a rising tide of cases for a second consecutive week as most states moved forward with reopening their economies.