Hyderabad-based pharmaceutical company Natco Pharmaceuticals said United States Food and Drug Administration (USFDA) issued nine observations after an inspection at Natco\u2019s formulation facility in Kothur, Hyderabad.\n\n\n\nNatco said it believes that most of the observations were \u2018procedural\u2019 in nature and not pertaining to data integrity. \n\n\n\nNatco said that it will address the USFDA observation within the next 15 working days to get the inspection report.\n\n\n\nProcedural observations are referred to as deficiencies in standard operating procedures in production, testing and hygiene. They are considered relatively easy to address than critical and mildly critical observations.\n\n\n\nData Integrity related observations refer to the completeness, consistency, and accuracy of data, which should be attributable, legible, original, and accurate.\n\n\n\nPost-inspection observations of the FDA are given in a \u2018Form 483\u2019. In a Form 483, the FDA typically outlines conditions or practices at a drug-making unit that may cause the products made there to be in violation of the US agency\u2019s standard production requirements.\n\n\n\nNatco said that some of the observations in the Form 483 included a failure to submit a Field Alert Report (FAR) after the detection of OOS (Out of Specification), a delay in the approval of annual product reviews of one of it\u2019s products and no proper documentation of the inspection of products.\n\n\n\nOOS refers to the results of in process or finished product testing that falls out of the established acceptance criteria in drug application regulations. \n\n\n\nThe inspection was carried out from May 30 to June 5.\n\n\n\nEstablished in 1981, Natco Pharma develops, manufactures and markets finished dosage formulations (FDF) and active pharmaceutical ingredients (APIs).\n\n\n\nApart from Kothur, Natco have two formulations facilities in Dehradun and one each in Telangana and Guwahati. It only has two chemicals manufacturing facilities, one in Chennai and one in Telangana.