USFDA issues EIR for Aurobindo Pharma Andhra Pradesh facility
New Delhi: Drugmaker Aurobindo Pharma Ltd has announced that the company has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its manufacturing facility at Pydibhimavaram in Andhra Pradesh.The company's Unit XI at Pydibhimavaram is an API non-antibiotic manufacturing facility. It was inspected by the USFDA in February 2019, and issued...
New Delhi: Drugmaker Aurobindo Pharma Ltd has announced that the company has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its manufacturing facility at Pydibhimavaram in Andhra Pradesh.
The company's Unit XI at Pydibhimavaram is an API non-antibiotic manufacturing facility. It was inspected by the USFDA in February 2019, and issued a warning letter in June 2019.
It was inspected further by the USFDA from July 25 to August 2, 2022, and issued a Form 483 with three observations.
Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Read also: Aurobindo Pharma gets 3 USFDA observations for Andhra Pradesh facility
"Subsequent to our responses for the aforesaid observations, we have received an EIR classifying the inspection as Voluntary Action Indicated (VAI) from the USFDA, and with this, the inspection at our Unit XI is concluded," Aurobindo Pharma said in a regulatory filing.
As per the USFDA, VAI classification is given when objectionable conditions were found and documented during the inspection, but the agency is not prepared to take or recommend regulatory action.
Read also: Aurobindo Pharma US arm gets USFDA EIR for Raleigh facility
Aurobindo Pharma Limited is a global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 155 countries.
The company has 27 manufacturing and packaging facilities that are approved by leading regulatory agencies, including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. The company's product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic.
Read also: Aurobindo Pharma net profit drops 41 percent to Rs 409 crore in Q2
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