Most Common FDA 483 Inspection Observations in 2020
March 27th, 2022 // 3:00 pm @ jmpickett
By reviewing the most common FDA 483 inspection observations, it’s possible for pharmaceutical companies to get a better grasp of how to organize their facility procedures and personnel.
We recently came across FDA data that revealed some of the most common 483 observations for 2020:
Absence Of Written Procedures
In 2020, FDA failed to find written procedures in 197 inspections. Companies were often not following one of the most important aspects of drug operations – writing down what you do and doing what you wrote down.
About 50% of these observations were about stability studies. Your company should have SOPs, standard test procedures, and protocols for all products and procedures.
How To Survive Your Next FDA Inspection
Most of the cited companies had written procedures but don’t follow them regularly, and this face was noted in the FDA cgmp inspection.
To eliminate this problem, correct training for all company procedures needs to be provided to every employee involved. The workers also must be required to follow SOPs and use good documentation practices.
Data Integrity Problems
Insecure data in computer systems was found in 125 cGMP inspections in 2020. Control records and master production records need to be fully accessible to only authorized employees.
Physical or digital records have to be secure and backed up according to schedule. Data integrity is a common issue for pharmaceutical companies because hackers are getting better every day.
Failure To Investigate Discrepancies
Failure to investigate discrepancies was noted 107 times in 2020 in FDA inspections. Companies failed their audit for not investigating batch failures and components of the batch, which were not always within specified limits.
FDA requires drug companies to conduct full investigations for every discrepancy, including OOS, out of trend, and deviation or failure that happened in the drug plant or QC lab. Every failed batch needs to be investigated to determine the root cause.
Cleaning, Sanitizing, And Maintenance
Cleaning issues in drug companies were seen 81 times by FDA auditors in 2020. Thorough cleaning of utensils and equipment used in drug manufacturing is essential to produce quality pharmaceuticals.
It’s also necessary to sanitize all equipment before using it to ensure all microbial contamination is removed. A study needs to be done to determine the hold time period for equipment that was cleaned during which the equipment can be used within being cleaned again.
A study also is needed to be done to determine the hold time study for dirty equipment. A cleaning validation study should be done to find the worst case as well. Things that should be reviewed, FDA states, include the equipment chain, number of batches per year, cleanability, and solubility.
Environmental Monitoring
Insufficient environmental monitoring was found 75 times in FDA audits of drug companies in 2020. Many drug companies don’t put enough focus on environmental monitoring, particularly in oral dosage drug facilities. But FDA expects environmental monitoring to be followed in oral dosage facilities, including sterile drug facilities.
The company must use a proper environmental monitoring program in all classified parts of the facility. And environmental monitoring must be done with schedule intervals and trends should be prepared and monitored.
