FDA 483 - Accugen Laboratories, Inc. - February 13, 2024

Accugen Laboratories, Inc. in Addison, IL, a control laboratory, was inspected from February 9-13, 2024, and received four observations related to significant deficiencies in quality control, facility maintenance, and equipment procedures. The inspection revealed issues including unreviewed data logger records leading to uninvestigated temperature excursions, inadequate complaint handling, unsanitary laboratory conditions with uncleaned media spills and dead insects, and poorly maintained equipment due to a lack of proper maintenance procedures. These findings indicate a general lack of adherence to good manufacturing practices concerning data integrity, quality system oversight, and facility upkeep.