FDA Issues Warning Letters to multiple companies

In July 2025, the FDA issued Warning Letters to several pharmaceutical and medical device manufacturers, as well as online pharmacies, for violating Current Good Manufacturing Practices (CGMP) and Quality System Regulations (QSR), and for selling unapproved drugs.

The main issues highlighted included shipping products after a fire without proper quality verification, an insufficient investigation into deficiencies in test results, defects in product design and manufacturing procedures, a failure to inspect raw materials and finished products, and the illegal sale of unapproved drugs.

These violations are believed to compromise product safety and efficacy, thereby increasing health risks to consumers.

•  • Shipping products without quality checks after the fire is a dangerous decision.
•  • Inadequate response to incomplete test results – neglecting data integrity.
•  • Defects in product design and manufacturing procedures create vulnerabilities in the entire system.
•  • Failure to inspect raw materials and final products: breakdown of basic QC processes.
•  • Illegally selling unapproved drugs: serious compliance violations due to disregard for regulations.

Business impact of the Warning Letter

Immediate costs:

•  • Increased frequency and extended duration of FDA inspections.
•  • Significant delays to the 510(k) approval process.
•  • Sales losses due to product recalls and shipment suspensions.
•  • Loss of trust from customers and investors.

Double risk under the current tariff environment:

•  • 15% tariff × FDA warning letter = fatal competitive disadvantage.
•  • Increased tariff costs and expanded opportunity losses
•  • Widening gap with competitors (South Korea: 15%; Brazil: 10%)
•  • Increased difficulty in securing a position in the US market

At Globizz, we are forming an FDA inspection response team and conducting pre-audits with the help of external experts. We are also reviewing 510(k) application strategies and conducting risk assessments of the entire supply chain.

If you have any questions about CGMP/QSR compliance, verification of compliance status or strategic risk management, please feel free to contact us.

Source: " RF Regulatory Focus News and Peer Reviewed Content "FDA warns firms for CGMP, QSR violations; online retailers cited for selling unapproved drugs"

Contact