Syntese has received a Form 483 after an inspection revealed sanitation, quality and laboratory control issues at the Denmark-based API maker.

The form listed five observations, including that the firm had not investigated out-of-specification test results for several batches of a finished product. Additionally, the firm did not conduct any microbiological tests on its API prior to its release to the U.S. market.

Another observation was that the quality control unit has no oversight when it comes to reviewing raw data, such as laboratory worksheets, chromatograms, audit trials and the overall integrity of data prior to releasing raw material for use in production and finished APIs.