Audits and Inspections

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The Importance of Appropriate Supplier Oversight

November 2nd 2024

The product license holder must have a supplier oversight system in place, says Siegfried Schmitt, PhD, vice president, Technical, Parexel.

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Keeping Audit and Inspection Programs Current

September 2nd 2024

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Post-Warning Letter Interaction with FDA

July 2nd 2024

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FDA’s Office of Pharmaceutical Quality Reports on 2023 Quality Assessments

April 4th 2024

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Are You Ready for Inspection?

January 2nd 2024

More News

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Warning Letter: Southern Meds

Pharmaceutical Technology Editors
February 24th 2006

Warning Letter: Southern Meds

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Warning Letter: Nephron Pharmaceuticals

December 14th 2005

FDA issues a warning letter to Nephron Pharmaceuticals.

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Warning Letter: Diversified Manufacturing

Pharmaceutical Technology Editors
November 9th 2005

This week, the US Food and Drug Administration posted an Oct. 20 Warning Letter (http://www.fda.gov/foi/warning_letters/g5567d.htm) sent by its Minneapolis, MN district office to Diversified Manufacturing Corporation (Newport, MN).

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CEPH International Replies to FDA Warning Letter

Pharmaceutical Technology Editors
October 6th 2005

CEPH International Replies to FDA Warning Letter

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Warning Letter: Similasan

September 8th 2005

Warning Letter: Similasan

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Warning Letter: Cape Drugs

August 18th 2005

Warning Letter: Cape Drugs

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Warning Letter: Merck & Co.

August 4th 2005

Warning Letter: Merck & Co.

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Warning Letter: Pragmatic Materials

June 30th 2005

Warning Letter: Pragmatic Materials

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Warning Letter: C&M Oxyfill

June 9th 2005

Warning letter: C&M Oxyfill

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Warning Letter: Palace Pharmacy

Pharmaceutical Technology Editors
April 7th 2005

Warning Letter: Compounding at Palace Pharmacy

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Warning Letters: DanChem Technologies and Medsep

Pharmaceutical Technology Editors
March 10th 2005

Warning Letters: DanChem Technologies & Medsep

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Warning Letter

January 27th 2005

FDA cites Essential Pharmacy Compounding (Omaha) for bulk-compounding of verterinary drugs.

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FDA Warning Letters December 2004

January 12th 2005

FDA Warning Letters December 2004

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