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5 Most Common 483s in FDA Inspections( Intertech Labs)Director T.Raja Rao
483 observations in FDA inspections are repeated frequently in different Firms. The same observation is reported many a time in a year
but firms are not focusing to address these issues as precedents . These common issues could be addressed before any inspection.
FDA emphasize 5 frequent common observations and the ways to address their possible occurrence during FDAinspection.
1. Absence of SOPs/Policy documents
FDA did not find written procedures 197 times in last one year in different pharmaceutical manufacturing facilities. Companies were
not following the thumb rule of pharmaceuticals i.e. “Do that is written and write that is done.” About 50% of these were related to
stability studies. Documents like SOPs, protocols, STPs and especially for stability studies must available for every procedure and
product in the company.
Most of the companies have written procedures but people don’t follow those procedures and caught in the inspection. To eliminate
this issue proper training of the procedures must be provided to all concerned. Employees must be clearly instructed to refer to SOPs
before starting any operation.
2. Data Integrity Issues
Data in computer systems (PLC/Software based) and even paper documented archived raw data was not found secure 125 times during
inspection in last one year. Master production and controlrecords and other documents like SOPs, STPs and records must be ac cessible
to authorized personnel only. Digital or physical records must be protected and backed up
Data integrity is a common issue in pharmaceuticals these days. FDA and WHO recently published their data integrity guidelines. This
is a frequent issue but very easy to eliminate and don’t require to work hard.
3. Failure to Investigate the Discrepancies
This issue was observed 107 times in last one year during FDA inspections. Firms were failed to investigate batch failure or any
component of the batch which was not within the specified limits. FDA says to conduct a proper investigation for each and every
incidence, event, deviation or failure that happened in the manufacturing facility. Each failed batch or test must be thoroughly
investigated to its actual root cause even though the batch is not released for the distribution.
4. Cleaning, Sanitizing and Maintenance
Cleaning issues in manufacturing are observed 81 times in a period of last one year. Proper cleaning of equipment and utensils used in
manufacturing is essential to manufacture a quality product. It is also required to sanitize equipment before its use to remove any
microbial contamination. A study must be conducted to find out the hold time period for cleaned equipment during which period
equipment can be used without re-cleaning.
5. Environmental Monitoring
Environmental monitoring was not found adequate 76 times in different companies in last one year. Many companies don’t take
environmental monitoring seriously especially in oral dosages manufacturing facilities. But FDA takes it seriously too and expects
environmental monitoring to be followed in oral dosages forms like sterile facility. A proper environmental monitoring program must
be prepared and implemented in all classified areas of the facility.
All of the above 483 observations are a result of the ignorance of the personnel of different departments. Companies must aware the
employees not to ignore or bypass anything and proper training must be conducted for the same. Some times extra workload or
manpower shortage may also be the root cause for the same.