Tag: OOS Investigations

Data Integrity, Cleaning Issues: Granule

USFDA inspected Granules India’s  Finished Dosage and PFI facility (FEI 3004097901) at Gagillapur Village, Hyderabad

USFDA 483 to Torrent: Concerns on Handli

With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary, Veena Raj The USFDA Form

Warning letter Sun Pharma Dadra Unit: In

Sun Pharma’s Dadra Unit was issued FDA Warning letter in June 2024, following critical observations

Deficient Method Validations, Aseptic ar

Cipla facility at Verna, Goa was audited by USFDA during June 2024 ending with issuance

FDA 483 to DRL : Issues in Analytical Va

USFDA 483 issued to Dr.Reddys (DRL) API unit in Pydibhimavaram, India cites failure to validate

Two more Product Recalls by Eugia for Im

Eugia US LLC is recalling two more injectable products in US for failed impurities, degradation

Sun Pharma Dadra USFDA 483 cites Lack of

Sun Pharma Dadra unit was inspected by USFDA in December 2023 by FDA investigator Pratik

Cipla Patalganga USFDA 483 highlights Cl

USFDA inspection of Cipla, Patalganga site manufacturing APIs and Tablets resulted in USFDA 483 with

USFDA 483 to Sun Pharma points to lack o

The USFDA 483 issued to Sun Pharma, Dadra unit in India (FEI 3004561553) published by

Warning letter to Australian API manufac

USFDA Warning letter to Australian API manufacturer cites basic laboratory compliance issues – Inadequate OOS