FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Swedish Drugmaker Hit for Equipment Security, Testing Issues

Jan. 11, 2019

The FDA hit Swedish drug manufacturer Apotek Produktion & Laboratorier with a Form 483 for failure to reject inadequate drug products and to secure analytical equipment at its facility in Stockholm.

In a May 28-June 1, 2018, inspection, the FDA investigator found instances in which the company did not reject drug products that failed assay tests. Specifically, three lots of capsule drug products failed to meet specifications. Two of the three lots were retested and failed again, but all three lots were released.

The firm also failed to secure all of its analytical equipment. For example, one instrument used to run identification tests on raw materials generated raw data that could be deleted. In another case, analytical balances located in the facility’s analytical laboratory and quality control lab were not adequately secured, as the date and time could be changed.

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