ARTICLE

FDA CGMP Inspections: Compliance Insights

In November 2025, the FDA continues to prioritize compliance through its rigorous CGMP inspection process. Over 90% of facilities inspected are found compliant, although issues are documented via Form FDA 483. Companies...

REGULATORY · FDA

New FDA Guidance on High-Risk Component Testing

As of May 2023, the FDA mandates immediate testing for high-risk components, such as glycerin, to check for diethylene glycol and ethylene glycol. This guidance is crucial for...

REGULATORY · FDA

DSCSA Compliance for Drug Supply Chain

The Drug Supply Chain Security Act (DSCSA) requires interoperable electronic tracing of prescription drugs across the supply chain, enhancing security and compliance.

REGULATORY · FDA

Insights from Recent FDA Inspections

In 2024, the FDA conducted nearly 15,000 inspections, issuing approximately 1,800 citations. These inspections reveal critical vulnerabilities in supply chains that companies must address.

MANUFACTURING · FDA

CGMP Compliance Checklists for CDMOs

FDA's inspection readiness checklists emphasize compliance with 21 CFR Parts 210/211, focusing on documentation, training, and facility maintenance for Contract Development and Manufacturing Organizations (CDMOs).

MANUFACTURING · FDA

DEA Compliance for Controlled Substances

The V5 Traceability platform ensures compliance with DEA quotas and material balance for controlled substances, enhancing the integrity of drug manufacturing processes.

MANUFACTURING · FDA

Importance of Upstream Supplier Qualification

FDA mandates that CDMOs perform raw material identity testing per lot, ensuring that all materials meet safety and quality standards.