- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
USFDA issues 2 observations for Dr Reddy's Labs Srikakulam facility
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)...
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.
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
Read also: Dr Reddy's Labs unit inks drug discovery, development pact with EQRx
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751