FDA has released on its web site a summary of all Fiscal Year (FY) 2010 inspections, including the Turbo-EIR form 483 observations and the frequency at which each was cited. During that period, there were 646 observations given in the area of drugs, 232 for veterinary medicine products and 224 for biologics.
The top five citations from 21 CFR were:
● 211.22(d) – Procedures not in writing, fully followed.
The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. 
● 211.100(b) – SOPs not followed / documented.
Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. 
● 211.192 – Investigations of discrepancies, failures.
There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. 
● 211.160(b) – Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. 
● 211.110(a) – Control procedures to monitor and validate performance.
Control procedures are not established which [monitor the output] [validate the performance] of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.