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FDA Inspection at Bioberica Nets 5-item 483

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An FDA January inspection at Bioiberica (Barcelona, Spain) leads to a five-item Form FDA-483 that cited significant GMP violations...

CBER Plans to Normalize Operations in 2023

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CBER updates its prioritization schedule for the remainder of 2022 to account for Covid-19-related work, while it plans to return ...

LabCorp Gains EUA for Covid Lineage Test

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FDA grants an emergency use authorization for Laboratory Corp. of Americas VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequ...

Green Pharma Recalls SnoreStop Lot

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Green Pharmaceuticals recalls one lot of its SnoreStop NasoSpray after FDA testing found the product contained a microbial contami...

FDA Clears 2 Thermo Scientific Tests

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FDA clears Thermo Scientific 510(k)s for its EliA RNA Pol III and EliA Rib-P tests for aiding in the diagnosis of systemic scleros...

DoJ Defends 'Fraud-on-FDA' in 1 Specific Case

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Sidley attorneys say the Justice Department voiced strong support for a fraud-on-FDA theory of liability in a case involving blood...

Some Mole Products Can Injure, Scar: FDA

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FDA cautions consumers not to use products marketed as mole or skin tag removers.

Foundation Medicine Companion Diagnostic Approved

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FDA approves a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for the two approved indicat...

Concerns on Drug Quality Metrics Proposal Aired

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Four additional stakeholders raise concerns about the FDA quality metrics proposal.

5 Observations on BPI Labs FDA-483

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FDA releases the FDA-483 with five observations issued following a 2021 inspection at Largo, FL-based BPI Labs.