Understand current Food and Drug Administration (FDA) regulatory guidance as well as current regulatory trends with regards to consent decree.

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
Thankyou !