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Software Validation

Identification of Software Validation Shortcomings

Software is used extensively in both the drug and device industry for computerized systems in manufacture and testing activities along with being used for building management control and equipment management control. GMP/GCP compliance failures in the drug product segment are no longer identified as the ‘software not being validated for its intended use’, but rather the deficiencies are now linked to the predicate GMP requirements based on FDA’s stated focus in 2010.

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FDA ARB Statement

Recent Statement Regarding ARB Recalls

Yesterday, Dr. Janet Woodcock, FDA Director of the Center for Drug Evaluation and Research, has released a statement regarding the recent recalls of Angiotensin II Receptor Blockers (ARB).

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Software Validation

Identification of Software Validation Shortcomings

Software is used extensively in both the drug and device industry for computerized systems in manufacture and testing activities along with being used for building management control and equipment management control. GMP/GCP compliance failures in the drug product segment are no longer identified as the ‘software not being validated for its intended use’, but rather the deficiencies are now linked to the predicate GMP requirements based on FDA’s stated focus in 2010.

Read More »