FDA Attorney Marc Sanchez discusses the Top FDA Form 483 (Inspectional Observations) from fiscal year 2013. The top observations provide a foundation for preparing for a pre-inspection, for-cause inspection, or routine surveillance inspection.

2. Top Form 483
Observations
Looking Back at 2013 for the Top Ten Observations from a Form 483

3. What is a Form 483
Form 483 is the most common enforcement tool for all FDA regulated products. FDA
Form 483, or Inspectional Observations, are a list of observations of possible small
and significant violations made by field investigators during an inspection. The
inspection can be routine surveillance, pre-inspection approval, or “for cause” during
a recall or other adverse event.
All significant
violations are
included in the
FDA Form 483
Observations
are reviewed by
a Dist. Director
along with the
Establishment
Inspection
Report
Only 10 days
to respond
Significant
violations lead
to a warning
letter. So does
a poor
response.
A written
response is
good practice
even if no
observations
are made.

4. Top Food Observations
The top ten food observations continues to be unchanged. This makes the list of observations
the best place to start mitigating or avoiding observations during a facility inspection.
21 CFR 110.35(c) 422 Lack of effective pest exclusion
21 CFR 123.11(b) 350 Sanitation monitoring
21 CFR 110.20(b)(7) 322 Screening
21 CFR 123.6(b) 244 HACCP plan implementation
21 CFR 110.20(b)(4) 237 Floors, walls and ceilings
21 CFR 110.35(a) 235 Buildings/sanitary
21 CFR 123.6(c)(3) 202 Critical limits
21 CFR 123.6(c)(4) 199 Monitoring - adequacy
21 CFR 123.6(c)(2) 198 Critical control points
21 CFR 110.80(b)(2) 194 Manufacturing conditions

5. Top Drug Observations
The top drug observations experienced the greatest change of the three categories included
here. Three new observations were lifted from lower in the list to the top ten.
21 CFR 211.22(d) 155 Procedures not in writing, fully followed
21 CFR 211.192 131 Investigations of discrepancies, failures
21 CFR 211.100(a) 106 Absence of Written Procedures
21 CFR 211.160(b) 99 Scientifically sound laboratory controls
21 CFR 211.67(b) 77 Written procedures not established/followed
21 CFR 211.113(b) 76 Procedures for sterile drug products
21 CFR 211.67(a) 71 Cleaning / Sanitizing / Maintenance
21 CFR 211.165(a) 66 Testing and release for distribution
21 CFR 211.110(a) 65 Control procedures to monitor and validate
performance
21 CFR 211.166(a) 62 Lack of written stability program

6. Top Device Observations
The top device observations are also surprisingly stable. Only one new observation moved from
lower in the list to the top ten.
21 CFR 820.100(a) 378 Lack of or inadequate procedures
21 CFR 820.198(a) 245 Lack of or inadequate complaint procedures
21 CFR 820.100(b) 133 Documentation
21 CFR 820.75(a) 127 Lack of or inadequate process validation
21 CFR 803.17 124 Lack of Written MDR Procedures
21 CFR 820.50 110 Purchasing controls, Lack of or inadequate procedures
21 CFR 820.90(a) 98 Nonconforming product, Lack of or inadequate
procedures
21 CFR 820.30(i) 93 Design changes - Lack of or Inadequate Procedures
21 CFR 820.181 77 DMR - not or inadequately maintained
21 CFR 820.22 73 Quality audits - Lack of or inadequate procedures

7. Inspections Conducted in 2013
Even amid the government shutdown an impressive and growing number of Form 483s were
issued. In 2013 5,050 Form 483s were formally recorded. There were additional unrecorded
informal warnings following inspections not accounted for in that sum.
Total Observations
Fiscal Yr 2013 Only.
Additional statistics, including for veterinary products, available upon request.
# Food Observations
This figure is down
slightly, but may be
account for by the
shutdown.
# Device
Observations
The figure is relative
stable, up by 9
observations from 2012.
# Drug Observations
This figure is also fairly
stable.
690
1099
2,386
5,050

8. Form 483 Response
Below is a brief overview of the steps to building a strong FDA Form 483
Response
Ask questions
if you are
unsure about
an observation.
A response
should
address each
observation
and issue
raised by
investigators.
Be specific in
how
observations
will be
corrected.
Avoid angry or
hasty
responses.
Avoid raising
legal
challenges
without
consulting an
expert.

9. Thank you!
msanchez@fdaatty.com
404.895.4882
“I have never found a more powerful and effective counsel.”
CEO Nature’s Rite Remedies