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The US Food and Drug Administration (FDA) had issued the observation letter after conducting an inspection at unit-III during April 10-18, 2017.
"The observations are all on procedural improvements. None of them are related to data integrity. The company will be responding as per the prescribed time lines," Aurobindo informed the stock exchanges on Wednesday.
The USFDA issues Form 483 to a pharma company at the end of inspection if it finds any violation of the Food Drug and Cosmetic Act. The company should respond to the form 483 with a corrective action plan and then implement that expeditiously.
Aurobindo has six formulations manufacturing facilities in India, one each in the US and Brazil. The Bachupally unit is an exclusive multi-product oral dosage form facility spread over 40,469 sq m for non-cephalosporins and non-beta-lactams.