Strides Pharma Gets Three USFDA Observations Following Alathur Facility Inspection

Susmita Roy

Strides Pharma Gets Three USFDA Observations Following Alathur Facility Inspection

Written By : Susmita Roy Published On 2026-09-13T19:15:24+05:30 | Updated On 13 Sept 2026 7:15 PM IST

Strides Pharma Divests Majority Stake in Pivot Path to Ascent Capital-Led Investors in Rs 100 Crore Deal

New Delhi: Strides Pharma Science Limited has informed that the United States Food and Drug Administration (USFDA) issued a Form 483 with three observations following an inspection of its formulations facility at Alathur, Chennai.

A routine current Good Manufacturing Practices (cGMP) inspection was conducted by the United States Food and Drug Administration (USFDA) at the Company's Formulations Facility at Alathur, Chennai during the period from September 2, 2026 to September 11, 2026.

Also Read:Strides Pharma Bengaluru Plant Gets 5 USFDA Observations, VAI Classification

At the conclusion of the inspection, the USFDA has issued a Form 483 with three observations.

The company said it would respond to the observations within the stipulated time.

"Company will respond to these observations to USFDA within the stipulated time. We will keep the stock exchanges informed if there is any further update in this matter." Strides Pharma Science added.

Also Read:Strides Pharma Divests Majority Stake in Pivot Path to Ascent Capital-Led Investors in Rs 100 Crore Deal

strides pharma scienceusfdainspectioncgmp inspectionusfda observation

Susmita Roy

Mpharm (Pharmacology)

Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

Print Article