Hyderabad-based pharmaceutical company Natco Pharmaceuticals said United States Food and Drug Administration (USFDA) issued nine observations after an inspection at Natco’s formulation facility in Kothur, Hyderabad.
Natco said it believes that most of the observations were ‘procedural’ in nature and not pertaining to data integrity.
Natco said that it will address the USFDA observation within the next 15 working days to get the inspection report.
Procedural 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.
Data Integrity related observations refer to the completeness, consistency, and accuracy of data, which should be attributable, legible, original, and accurate.
Post-inspection observations of the FDA are given in a ‘Form 483’. 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’s standard production requirements.
Natco 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’s products and no proper documentation of the inspection of products.
OOS refers to the results of in process or finished product testing that falls out of the established acceptance criteria in drug application regulations.
The inspection was carried out from May 30 to June 5.
Established in 1981, Natco Pharma develops, manufactures and markets finished dosage formulations (FDF) and active pharmaceutical ingredients (APIs).
Apart 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.
