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Featured Product In Inspections and Audits

FDA’s Alternative Inspection Tools

FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions

$397.00
If you want to pass your next inspection, FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions is a must. Read More

Inspections and Audits

Understanding EU Drug Safety Reporting

$397.00
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Poor Investigations Doom API Maker to Form 483

$157.00
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Expediting the FDA Generic Drug Approval Process

$397.00
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FDA Slaps Second Impax Plant with a Form 483

$157.00
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EU Regulators Seek Information on Products Tested by GVK Bio

$40.00
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Bribery Allegations Continue to Hound GlaxoSmithKline in China, Elsewhere

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FDA Warns Italian API Maker for Deleting Quality Data

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Compounding Pharmacy Relents to FDA’s Recall Request

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FDA Issues Safety Alert for Texas Compounder’s Products

$157.00
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FDA Releases Slew of Warnings to Compounding Pharmacies

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Lack of Testing, Data Integrity Means 483 for OTC Drugmaker

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No Batch Records or Inspections Lands API Maker a Form 483

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