Archive · 21 Nov 2025
USFDA Issues 7 Observations to Natco Pharma's Chennai API Unit
The US Food and Drug Administration (USFDA) visited Natco Pharma's Active Pharmaceutical Ingredients (API) factory in Chennai, India.
They found 7 small issues that Natco Pharma is going to fix.
These issues won't affect the quality of the medicines made there.
USFDA inspected Natco Pharma's API Unit in Chennai, India from Nov 17-21, 2025
7 observations were issued in Form-483
Observations are procedural in nature
Natco Pharma committed to addressing observations and maintaining cGMP compliance
No impact on product quality or supply
- Who
- USFDA, Natco Pharma
- What
- Inspection of Natco Pharma's API Unit in Chennai
- When
- November 17-21, 2025
- Where
- Manali, Chennai, India
- Why
- To ensure quality and compliance with regulations
- Inspection Duration
- 5 days
- Number of Observations
- 7
- Observation Nature
- Procedural
- Natco Pharma's Response
- Committed to addressing observations and maintaining cGMP compliance