Unit I is an API manufacturing facility of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Borpatla Village, Hatnoor Mandal, Sangareddy District, 502296, Telangana.
The EIR follows the warning letter issued in 2022. In 2025, the USFDA carried out a for-cause inspection at the facility from August 21 to August 29, 2025, after which it issued a Form 483 with 5 observations.
The USFDA has now completed its evaluation of the corrective actions submitted in response to Warning Letter dated January 14, 2022 including subsequent 5 observations from Form 483 and has determined that the issues cited in the Warning Letter & Form 483 have been adequately addressed. Accordingly, the Warning Letter is considered closed.
The Unit has now received EIR classifying the facility as "Voluntary Action Indicated" ("VAI").
VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action
USFDA has concluded that this inspection is closed.
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Aurobindo Pharma Limited is an integrated 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 150 countries. The company has 31 manufacturing and packaging facilities that are approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, 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, supported by a R&D set-up.
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