The FDA hit Surmasis Pharmaceutical of Des Moines, Iowa with a Form 483 after a February inspection revealed problems with laboratory records, computer systems and equipment inspections.
The agency investigators noted that the firm’s laboratory records did not include all data collected from tests, examinations and assays. Electronic data collected from software that was used to perform lab analyses was not reported in the firm’s official test results because a failing test was omitted from the analyst’s lab notebook and certificate of analysis. In addition, software audit trails showed multiple instances of unreported testing.
The firm also failed to control its computer systems to assure that changes in master production and control records could only be done by authorized staff. Software the firm used to perform a variety of physical tests did not require users to save test results. In addition, it allowed users to alter what test name is reported in the audit trail, and allowed two different individuals to share passwords to a computer’s administrator account.