USFDA issues 2 observations for Dr Reddy's Labs Srikakulam facility

Published On 2022-07-08 06:01 GMT   |   Update On 2022-07-08 06:01 GMT

New Delhi: Drugmaker, Dr Reddy's Laboratories, has recently announced that the United States Food & Drug Administration (USFDA) has issued a Form 483 with two observations after a PreApproval Inspection (PAI)  at its manufacturing facility located at Srikakulam in Andhra Pradesh.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
"This is to inform you that the United States Food & Drug Administration (USFDA) today completed a PreApproval Inspection (PAI) at our formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh," the company stated in the BSE filing.

The inspection was conducted from 30th June, 2022 to 7th July, 2022.

"We have been issued a Form 483 with two observations, which we will address within the stipulated timeline," the company further stated.

Read also: Dr Reddys acquires injectable product portfolio from Eton Pharma for Rs 391 crore

Dr. Reddy's Laboratories Ltd. is an integrated pharmaceutical company headquartered in Hyderabad, Telangana, India. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology.
Dr. Reddy's operates in markets across the globe. The company's major markets include - USA, India, Russia & CIS countries, and Europe.

Read also: Dr Reddy's Labs unit inks drug discovery, development pact with EQRx

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News