26 C
Guwahati
Thursday, December 5, 2024

USFDA issues Form 483 with 5 procedural observations to Torrent Pharma’s Gujarat unit

- Advertisement -
- Advertisement -

NEW DELHI, Dec 12: 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.

- Advertisement -

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.” (PTI)

- Advertisement -
The Hills Times
The Hills Timeshttps://thehillstimes.in/
Welcome to The Hills Times, your trusted source for daily news and updates in English from the heart of Assam, India. Since our establishment in 2000, we've been dedicated to providing timely and accurate information to our readers in Diphu and Guwahati. As the first English newspaper in the then undemarcated Karbi Anglong district, we've forged a strong connection with diverse communities and age groups, earning a reputation for being a reliable source of news and insights. In addition to our print edition, we keep pace with the digital age through our website, https://thehillstimes.in, where we diligently update our readers with the latest happenings day by day. Whether it's local events, regional developments, or global news, The Hills Times strives to keep you informed with dedication and integrity. Join us in staying ahead of the curve and exploring the world through our lens.
Latest news
- Advertisement -
Related news
- Advertisement -
10 Indian Breakfast Dishes Loved Across The World 10 Places To Visit In Kashmir For Honeymoon In Winter Popular South Indian Saris You Should Know 10 Birds to Spot in North East India 10 Beautiful Lakes In South India