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Repeat Deficiencies in Lupin Limited Warning Letters

When observations are identified during an inspection, it is FDA’s expectation that a firm will remediate the issues. This expectation is even more important if a firm receives a warning letter. Lupin Limited (India) seems to have come up short on both accounts.

Recent Posts

Software Validation

Identification of Software Validation Shortcomings

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

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 »