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News about "US FDA Inspection"
Granules India's Gagillapur Plant Gets 11 US FDA Observations
Granules India’s Gagillapur facility has received 11 US FDA observations, with none related to data integrity or cross-contamination.
US FDA Inspection | 02/11/2026 | By News Bureau
US FDA Inspection of Unichem's Goa Facility Ends With 5 Observations
US FDA conducted a six-day inspection at Unichem Laboratories’ Goa formulation facility, concluding with five observations related to procedural enhancements.
US FDA Inspection | 30/09/2026 | By News Bureau | 119
Aurobindo Pharma's Lannett Facility Completes US FDA Inspection with 4 Observations
Aurobindo Pharma’s Lannett facility in Indiana completes a US Food and Drug Administration (FDA) inspection with 4 procedural observations and will respond within the stipulated timeline.
US FDA Inspection | 24/08/2026 | By News Bureau
Aurobindo Pharma's Raleigh Plant Receives VAI Classification from US FDA
Aurobindo Pharma’s Raleigh plant receives Voluntary Action Indicated (VAI) classification from the US Food and Drug Administration (FDA), closing the inspection and allowing pending inhaler and dosage-form applications to progress.
US FDA Inspection | 17/08/2026 | By News Bureau | 157
Aurobindo Pharma's Eugia Unit I Receives US FDA Warning Letter
Aurobindo Pharma’s Eugia Pharma Unit I receives a US Food and Drug Administration (FDA) Warning Letter following OAI status, with no impact on existing US supplies.
US FDA Inspection | 14/08/2026 | By News Bureau | 404
Cipla's InvaGen Receives US FDA EIR for New York Manufacturing Facility
Cipla's subsidiary InvaGen has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA), marking the successful closure of the inspection at its New York facility.
US FDA Inspection | 04/08/2026 | By News Bureau | 155
US FDA Classifies Aurobindo Pharma's Eugia Unit-III Inspection as Official Action Indicated
Aurobindo Pharma said the US FDA has classified its inspection of Eugia Unit-III in Telangana as Official Action Indicated, while reaffirming its commitment to maintaining global quality manufacturing standards.
US FDA Inspection | 16/06/2026 | By News Bureau | 352
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