We note that none of the three observations issued in the recent inspection are related to data integrity- which is a positive sign for the company, in our view. The first observation points out the lack of defined area to prevent contamination in operations related to aseptic processing of drugs. The second observation mentions that the written procedures for cleaning and maintenance do not clearly provide details of the methods to disassemble and reassemble equipment. The third observation is related to written procedure giving details of sampling, testing,approval and rejection of drug product containers and closures.