Warning Letters Signal Steps to Compliance

Warning letters tell the tale of missteps by drug companies and offer a path to compliance for quality teams that monitor these enforcement actions.

While the number of warning letters issued by FDA has declined slightly, recurrent violations include poorly maintained equipment and facilities, insufficient cleaning validation, inadequate written procedures for quality testing, and inadequate controls over data and computer systems. Effective, ongoing monitoring programs-for regulatory agency enforcement actions and pharmacopoeia updates-are essential for bio/pharma compliance.

Read this article in BioPharm International’s December 2019 Regulatory Sourcebook.

Article Details

BioPharm International
eBook: Regulatory Sourcebook, December 2019
December 2019
Pages: 3–4

Citation

When referring to this article, please cite it as R. Peters, “Warning Letters Signal Steps to Compliance," BioPharm International Regulatory Sourcebook eBook (December 2019).

Articles in this issue

almost 6 years ago

Article

Revision Process for Global/National Pharmacopoeias (eBook)

almost 6 years ago

Article

Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions (eBook)

almost 6 years ago

Article

Lessons from FDA 483s and cGMP Inspection Data

almost 6 years ago

Article

Resources, Guidelines, and Guidance Documents

almost 6 years ago

Article

Regulatory and Standard Setting Organizations

almost 6 years ago

Article

Quality Risk Management Plans Create Effective Quality Systems

Newsletter

Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.

Subscribe Now!