The US FDA released enforcement data from fiscal year 2013. The data provides the total number of Form 483 Inspectional Observations, the most common pre-enforcement tool used by the agency, for the prior year. Comparing the new data to fiscal year 2012 provides insight into the Agency’s enforcement priorities. The informal review below again shows the majority of top observations remains unchanged for the past several years. The trap is set for 2014 for facilities not taking note of the trends.
This year’s report changes a trend of increasing inspectional observations. The total Form 483s issued was down for the first time with the FDA issuing 747 fewer form 483s in 2013 than in 2012. The likely culprit is the government shutdown in October. In the three major categories, drugs, devices, and food/dietary supplements only devices saw an increase in the number of Form 483s issued. The table is below.
This year’s report again shows the top ten observations in the three major categories review was largely unchanged. The top ten in food/dietary supplements remained completely unchanged. This has been the trend for the past several years. The top ten for food/dietary supplements will likely remain consistent until new Food Safety Modernization Act changes begin to appear. The lesson for food/dietary supplement facilities is to inspect the top-ten observations and plan accordingly.
Both device and drug saw some changes in the top-ten observations. The device category’s top five observations were the same as 2012. The only change was to #9, which previously was investigations of device failures, is now maintenance of the Master Device Record (MDR). Investigations of device failures fell four places to #14 on the top observation list.
|3130||21 CFR 820.100(a)||378||Lack of or inadequate procedures|
|14713||21 CFR 820.198(a)||245||Lack of or inadequate complaint procedures|
|3696||21 CFR 820.100(b)||133||Documentation|
|546||21 CFR 820.75(a)||127||Lack of or inadequate process validation|
|630||21 CFR 803.17||124||Lack of Written MDR Procedures|
|479||21 CFR 820.50||110||Purchasing controls, Lack of or inadequate procedures|
|3282||21 CFR 820.90(a)||98||Nonconforming product, Lack of or inadequate procedures|
|3103||21 CFR 820.30(i)||93||Design changes – Lack of or Inadequate Procedures|
|3331||21 CFR 820.181||77||DMR – not or inadequately maintained|
|2327||21 CFR 820.22||73||Quality audits – Lack of or inadequate procedures|
The drug category experienced the greatest turnover from FY 2012. Three new observations made the top-ten list – procedures for sterile drugs, testing and release before distribution, and lack of written stability program. The change in the list may be the result of the FDA’s blitz on compounding pharmacies following a rash of illness last year.
|1105||21 CFR 211.22(d)||155||Procedures not in writing, fully followed|
|2027||21 CFR 211.192||131||Investigations of discrepancies, failures|
|1361||21 CFR 211.100(a)||106||Absence of Written Procedures|
|3603||21 CFR 211.160(b)||99||Scientifically sound laboratory controls|
|1215||21 CFR 211.67(b)||77||Written procedures not established/followed|
|1451||21 CFR 211.113(b)||76||Procedures for sterile drug products|
|1213||21 CFR 211.67(a)||71||Cleaning / Sanitizing / Maintenance|
|1883||21 CFR 211.165(a)||66||Testing and release for distribution|
|3585||21 CFR 211.110(a)||65||Control procedures to monitor and validate performance|
|1914||21 CFR 211.166(a)||62||Lack of written stability program|
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