The US FDA has classified the inspection of Apitoria Pharma Private Limited’s Unit-I as Voluntary Action Indicated (VAI). This follows a for-cause inspection in August 2025 and subsequent corrective actions. The FDA has closed its warning letter issued in January 2022, determining that the issues have been adequately addressed. Unit-I is an API manufacturing facility.
US FDA Classifies Inspection
The United States Food and Drug Administration (US FDA) has classified the inspection at Apitoria Pharma Private Limited’s Unit-I as Voluntary Action Indicated (VAI). This inspection included a review of corrective actions related to a warning letter issued in January 2022 and subsequent observations.
Inspection Details
The US FDA conducted a for-cause inspection at Unit-I from August 21 to August 29, 2025. Following the inspection, a Form 483 was issued with 5 observations. Unit-I is an API manufacturing facility of Apitoria Pharma Private Limited located in Telangana.
Resolution of Issues
The US FDA has completed its evaluation of the corrective actions submitted in response to the warning letter dated January 14, 2022, including the 5 observations from Form 483. The agency determined that the issues cited in the warning letter and Form 483 have been adequately addressed. As a result, the warning letter is now considered closed.
Establishment Inspection Report
Unit I has received an Establishment Inspection Report (EIR) classifying the facility as “Voluntary Action Indicated” (VAI). The FDA has concluded that this inspection is now closed. Receipt of the EIR with VAI classification is expected to positively impact the operations of the Unit.
Source: BSE
