Almost every major life sciences company has been under a settlement action or monetary penalty situation

1. 1
Regulatory Trends

2. 2
Regulatory Trends- An Ongoing Struggle
In the Life Sciences Industry, the cost of non-compliance has been especially acute.
1,600
• Almost every major life sciences company
has been under a settlement action or
monetary penalty situation
• Even though adoption of technology and
approvals of NMEs and devices increased,
regulatory events of significance have
increased too.
• Industry is spending at least $34B per year
on external compliance software and
services alone (Grand View Research)
Product
Recalls
Warning
Letters

3. 3
Pharma Industry Paying the Price

4. 4
Regulatory Trends- An Ongoing Struggle
MedicalDevicesPharma
• Since 2011, for the first time total number of 483
observations rose in 2015
• During 2011-15, more than 95% of total 483
observations cited Current Good Manufacturing
Practices for finished pharmaceuticals (cGMP, 21 CFR
Part 211) deficiencies
• In the medical device industry, 64% of the FDA Form
483’s issued in 2015 were due to quality system
deficiencies, mainly in Corrective and Preventive
Action (CAPA) and Production and Process Controls
(P&PC).

5. 5
Regulatory Trends- An Ongoing Struggle
Warning Letter Trends
• CDER and the Office of Prescription Drug
Promotion issued 47 warning letters in 2016, 52 in
2015 and 53 in 2014.
• In 2016, 15 warning letters issued by office of
manufacturing cited data integrity as major
concern.

6. 6
Causes of 483s within cGMP (Pharma)
978
872
731
606
751
695
661 649
557
681
580
551
525
431
546
523
462
424
384
421
422
366
346
326
351
283
264
221
157
224212
152
127
86
109
190
181 213
222
350
2011 2012 2013 2014 2015
Number of 483 Observations with cGMP Violations by Sub Parts
Records and Reports
Laboratory Controls
Production and process
controls
Organization and Personnel
Equipment
Control of Components and
drug product containers and
closures
Packaging and labeling control
Buildings and Facilities

7. 7
Major Reasons for Medical Device Recalls 2016
# General Description
Material that may split or break, Tip Separation
Defective Connectors, Leads, Seal Defects
Explosion Risk, Premature Discharge
Inconsistent, Invalid, Inaccurate readings
Inadequate Sterilization, Contamination QC Failure
Coating Separation, Coating Contamination
Sensor Signal Loss, Electrical Issues
Category
Material
Design Defects
Battery Issues
Inaccurate Test
Results
Sterilization /
Contamination
Coating
Electrical /
Signal Loss
* 39 Med. Device Recalls of 2016 - https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm480134.htm
NOTE: Major Cause of Recall Identified in the category.
9
9
7
6
3
3
2

8. 8
The Five Deadly Sins
%*
38
37
13
6
6
General Description
Rudimentary cGMP, release testing, cleaning, equipment maintenance, cross
contamination
Lack of Access control to computerized systems. Deletion, falsification,
manipulation. ‘Non-contemporaneous data’
Aseptic Techniques, compounding and conventional sterility assurance SOPs
Drug Substance/API repacking , relabeling, contract manufacturing deficiencies
Import Alert 99-32 (Not allowing for inspection)
Category
SOPs, Documents
Data Integrity
Sterility Assurance
Supply Chain
Delay/ Deny/ Limit/ Refuse
* Analyses of 52 Warning Letters issued by Office of Manufacturing Quality in 2016.
Data Courtesy of Ms. Paula Katz, OMQ US FDA

9. 9
Xybion Corporation’s Take
Mitigate 483 blues with Xybion’s secure cloud based solutions
for 21 CFR Part 11, GxP Compliance
Explore Xybion’s Digital Workplace Solution (DWS) For Today's Connected
Workforce
Learn more: https://www.xybion.com/total-compliance/
Call us: Sales @ 844 291 4430
Write to us: sales@xybion.com