Archive · 20 Jul 2025
Dr. Reddy's Srikakulam Plant Faces New USFDA Scrutiny
Imagine a company that makes medicine gets checked by the government to make sure everything is safe and done correctly.
The government inspector found some things that weren't perfect.
The company, Dr. Reddy's, makes medicine in Srikakulam and they got a list of 7 things they need to fix.
This isn't the first time this has happened, as there were similar issues found before.
The company has to respond to the government about how they'll fix these issues.
It's important because the government wants to make sure the medicine is safe and works well.
Dr. Reddy's Laboratories received a Form 483 with seven observations from the USFDA for its Srikakulam facility.
The inspection, encompassing GMP and PAI, occurred from July 10 to 18.
A Form 483 is issued when the USFDA finds potential violations of the Food, Drug and Cosmetic Act.
This is not the first time the Srikakulam plant has faced USFDA scrutiny, with prior observations in 2017 and June 2024.
The company's shares ended 0.4% lower on the day the disclosure was made.
- Who
- The US Food and Drug Administration (USFDA) inspected Dr. Reddy's Laboratories.
- What
- Dr. Reddy's Laboratories received a Form 483 with seven observations from the USFDA.
- When
- The inspection occurred from July 10 to 18. The disclosure was made on Sunday.
- Where
- The inspection took place at Dr. Reddy's formulations manufacturing facility in Srikakulam, Andhra Pradesh.
- Why
- The USFDA conducts inspections to ensure compliance with the Food, Drug and Cosmetic (FD&C) Act.
- Company
- Dr. Reddy's Laboratories
- Facility Location
- Srikakulam, Andhra Pradesh
- Regulatory Body
- USFDA
- Type of Inspection
- GMP and PAI
- Observations
- Seven
- Date of Inspection
- July 10 to 18
- Stock impact
- Ended 0.4% lower