A warning letter from the FDA is issued to manufacturers for significant regulatory violations, including noncompliance with good manufacturing practices and false product claims. Trends that may indicate impending warning letters include internal problems, Form 483 notifications, quality unit red flags, customer complaints, and repeated inspections. The document highlights the importance of being aware of these warning signs to maintain FDA compliance.

1. Anticipating FDA
Warning Letters?

2. WHAT IS A WARNING LETTER?
A Warning Letter is
issued by the FDA to a
regulated manufacturer
if it is found that any
significant regulatory
violations have
occurred.

3. Nonconformance with
Good Manufacturing
Practices (GMP)
False Claims About a
Product
Inadequate Training
for Personnel
Wrong directions for
Use and so on…
Violations Identified in Warning
Letters Include-

4. FDA Has Been Busy! (2000-2015)
300000+
Inspections
170000+
Facilities
130000+
483S
4500+
Inspectors

6. What Are The Trends?

7. WatchOutforWarningLetterSigns
• Long standing internal problems that
have not yet caught the attention of
the FDA but are known within the
company
• Form 483 notifications (the most
obvious predictor of Warning Letters)
• Red flags from the Quality Unit
• Adverse events
• High volume of customer complaints
• Prior investigations about the same
issue or same type of issue
• FDA responses to communications
from the company that do not signal
satisfaction with issue resolution and
so on
• Product contamination
• Off-Label Promotional activities that
have caught the attention of the FDA
• DDMAC letters
• Repeated FDA inspections of facilities

8. For more on FDA Compliance
Visit our Website
www.complianceonline
FDA Compliance
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