USFDA Inspection at Goa Formulation Facility Closes With 5 Observations
USFDA inspected the Goa formulation facility at Pilerne, Bardez from 21st September 2026 to 26th September 2026.
By ScoutQuest · · 1 min read
- Inspection Period
- 21st September 2026 to 26th September 2026
- Facility Location
- Goa formulation facility at Pilerne, Bardez
- Number of Observations
- five (5) observations
- Observation Type
- procedural enhancements
- Response Deadline
- 15 days
What happened
The United States Food and Drug Administration inspected the company's Goa formulation facility at Pilerne, Bardez from 21st September 2026 to 26th September 2026.
Outcome
- The inspection concluded with five (5) observations described as relating to procedural enhancements.
- The company will provide its response to the USFDA within the stipulated 15 days.
Why it matters
US regulators inspect plants that make medicines for the American market. Observations are issues noted by the inspectors at the close of an inspection; the company now has a set window to reply with corrective steps. The nature and number of observations, and the regulator's view of the response, determine what follows.
Also from Unichem Laboratories
Board meeting on November 4 to consider Q2 and H1 unaudited results, standalone and consolidated
21 Oct 2026
More numbers
- USFDA observationsfive (5) observations
- Response window to USFDA15 days
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