According to the company, USFDA conducted the inspection at Unit III of Yugi Pharma Specialties located in Sangareddy district of Telangana from January 2 to February 2.
"Subsequently, the USFDA has determined the inspection classification status of this facility as an indication of official action," Aurobindo Pharma said in a regulatory filing.
"The company is committed to working closely with the USFDA and enhancing its compliance on an ongoing basis," it added.
OAI means that objectionable conditions or practices were found, and/or the firm's response was not satisfactory, so regulatory and/or administrative action will be recommended.
In an enforcement report published earlier this month, the USFDA reported that Aurobindo Pharma is recalling products in the US due to manufacturing issues.
The drugmaker recalled 13,605 bottles of clorazepate dipotassium tablets (3.7 mg and 7.5 mg) from the US market. Clorazepate dipotassium tablets are used to treat anxiety.
"Subsequently, the USFDA has determined the inspection classification status of this facility as an indication of official action," Aurobindo Pharma said in a regulatory filing.
"The company is committed to working closely with the USFDA and enhancing its compliance on an ongoing basis," it added.
OAI means that objectionable conditions or practices were found, and/or the firm's response was not satisfactory, so regulatory and/or administrative action will be recommended.
In an enforcement report published earlier this month, the USFDA reported that Aurobindo Pharma is recalling products in the US due to manufacturing issues.
The drugmaker recalled 13,605 bottles of clorazepate dipotassium tablets (3.7 mg and 7.5 mg) from the US market. Clorazepate dipotassium tablets are used to treat anxiety.
