GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.

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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Home » Apotheca Cited for cGMP Violations in FDA Warning

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Apotheca Cited for cGMP Violations in FDA Warning

Sept. 10, 2012

FDA inspections of Apotheca have revealed possible metal shaving contamination and broken, leaking or damaged bottles for various drugs, resulting in a warning letter. The letter criticized Apotheca’s lack of a scientific justification for releasing potentially contaminated drugs. Further, Apotheca decided that investigations into 19 complaints associated with the bottle issues were unnecessary.
Drug GMP Report

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