Who Will Observe? Important Highlights from Warning Letter Wednesday in September

On September 17, 2025, Warning Letter Wednesday was sponsored by Global Key Solutions Corp., bringing John English, HCCP (Principal, John T English Consulting). The subject was timely and contentious: “Data Forgery in FDA Warning Letters”

Why Data Integrity Still Matters

Despite decades' worth of regulation, data falsification and data dishonesty are continually being brought to light through the life sciences space. John cited how oftentimes the reason revolves back to financial hardship, performance regarding stocks, and even visa-related concerns with employees, and little has changed regarding humanity over 20+ years.

Case Studies That Hit Home

• Able Labs (2005):

A "regulatory jolt" culminating in a recall of 3,000+ batches of goods. A warning letter was substituted by prosecution, to live on in infamy as the Curse of Cranbury, NJ.

• Boothwyn Pharmacy (June 2025):

Faked Certificates of Analysis (CoAs), forged investigation reports, and unauthorized veterinary medicine revealed system-wide failings of oversight.

• GLP Fraud in China (2025):

Jiangsu Kerbio Medical Tech recycled animals killed during studies and forged records when confronted by investigators.

CCIC Huatongwei International was found to photocopy signatures and information during various trials.

These "twin letters" shed light exactly how ingrained data manipulation can get.

• Catalent (Indiana, July 2025):

Systemic electronic failings, lack of audit trails, out-of-function log-on capacities, and invalidating systems, trigger FDA investigators' alarm bells.

• NATCO (India, June 2025):

The disparities between print and electronic data uncovered "fraud built into the system."

AI in Compliance: New Frontier, Old Responsibilities

There was an active discussion regarding the contribution of artificial intelligence to regulatory writing. Key points:

• AI is like a research assistant — useful at producing writing but requiring human checking and accountability.

• Firms need to assume clear policies and confirmations when submissions are made using AI. Regulators diverge: EMA is racing ahead with advice, while FDA is slowing down.

Accountability remains with the signatory, never with the AI technology.

What This Means for Quality Leaders

Auditing trail reviews and system verification remain major defenses. Education, responsibility, and verification of documents continue to be first-line data fraud defenses. Advanced plans can evolve and mature, yet those fundamentals of verification, compliance, and patient safety can't be evaded.

Global Key Solutions Updates

• 📍 Catch us at ISPE Boston Product Show - October 1 at Booth E34.
• 📰 Newly posted are blogs from the PDA, ASQ, and Rx-360 conference findings.
• 🎥 October is bringing The next Warning Letter Wednesday - mark your calendar!

Final Thoughts

"We can't be perfect. We can just try real hard."

• — John English

At a point when forgery and AI documents are possible realities, vigilance, policy, and human oversight are still the best integrity defenses.