FDA 483 - Joint Stock Company Grindeks - August 24, 2018

Joint Stock Company Grindeks, an API manufacturer in Riga, Latvia, received a Form 483 citing multiple deficiencies in its operations. Key issues included inadequate controls over electronic laboratory data, incomplete laboratory records, and inappropriate raw material sampling. The firm also failed to properly maintain and clean production equipment, ensure API conformance to specifications, and conduct thorough out-of-specification investigations.