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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

Warning letters issued by FDA can be an important source of data to study and analyse violations that occur in pharmaceutical manufacturing. Such studies can also help companies prepare for their upcoming inspections by enabling them to identify and rectify any issues.

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FDA warning letters highlight CAPA concerns

European Pharmaceutical Review

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. An FDA warning letter delivered to Edge Biologicals Inc. While RemedyRepack, Inc.

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