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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.
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Top Form 483 Observations
Looking Back at 2013 for the Top Ten Observations from a Form 483
What is a Form 483Form 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.
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
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
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
Inspections Conducted in 2013Even 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 ObservationsThe figure is relative stable, up by 9 observations from 2012.
# Drug Observations
This figure is also fairly stable.
690
1099
2,386
5,050
Form 483 ResponseBelow 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.
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