USFDA Issues Form 483 to Torrent Pharma Gujarat Unit
By Rediff Money Desk, NEWDELHI Dec 12, 2023 11:40
USFDA issued Form 483 with 5 procedural observations to Torrent Pharma's Gujarat oral manufacturing facility. The observations were not related to data integrity.
![USFDA Issues Form 483 to Torrent Pharma Gujarat Unit](https://im.rediff.com/money/2017/sep/21pharma.jpg)
New Delhi, Dec 12 (PTI) Torrent Pharmaceuticals Ltd on Tuesday said the US health regulator has issued Form 483 with five procedural observations after inspecting its oral manufacturing facility situated at Bileshwarpura in Gujarat.
As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The USFDA conducted a pre-approval Inspection at the company's oral manufacturing facility situated in Bileshwarpura, Gujarat from December 5 to 11, 2023, Torrent Pharma said in a regulatory filing.
"At the end of the inspection, the company was issued a Form 483 with five procedural observations. There was no observation related to data integrity reported,"it added.
The company also said, "we will respond to the USFDA within the prescribed time frame and will work in close collaboration with the agency to address the observations at the earliest possible time.
As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The USFDA conducted a pre-approval Inspection at the company's oral manufacturing facility situated in Bileshwarpura, Gujarat from December 5 to 11, 2023, Torrent Pharma said in a regulatory filing.
"At the end of the inspection, the company was issued a Form 483 with five procedural observations. There was no observation related to data integrity reported,"it added.
The company also said, "we will respond to the USFDA within the prescribed time frame and will work in close collaboration with the agency to address the observations at the earliest possible time.
DISCLAIMER - This article is from a syndicated feed. The original source is responsible for accuracy, views & content ownership. Views expressed may not reflect those of rediff.com India Limited.
TODAY'S MOST TRADED COMPANIES
- Company Name
- Price
- Volume
- Vodafone Idea L
- 17.90 ( -3.35)
- 166585989
- Alstone Textiles
- 0.75 (+ 8.70)
- 47681821
- GTL Infrastructure
- 3.27 (+ 4.81)
- 44040612
- Visagar Financial
- 0.91 (+ 12.35)
- 29755394
- YES Bank Ltd.
- 23.70 (+ 0.77)
- 22163699
MORE NEWS
![Piyush Goyal:...](https://im.rediff.com/80-80/money/2017/jan/11goyal.jpg)
Piyush Goyal: Govt Committed to Industrial...
Hyderabad, Jun 30 (PTI) Union Commerce Minister Piyush Goyal on Sunday said the...
![Piyush Goyal:...](https://im.rediff.com/80-80/money/2019/jan/23piyush.jpg)
Piyush Goyal: Govt Committed to Industrial...
Hyderabad, Jun 30 (PTI) Union Commerce Minister Piyush Goyal on Sunday said the...
![Indian Economy...](https://im.rediff.com/80-80/money/2020/nov/22economy.jpg)
Indian Economy Growth: Exports, Manufacturing &...
Mumbai, June 30 (PTI) Healthy increase in the country's exports, improvement in the...