Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Data Integrity, Cleaning Issues: Granule

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

Qvents Team
October 17, 2024

Deficient Method Validations, Aseptic ar

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

Qvents
June 30, 2024

FDA 483 to DRL : Issues in Analytical Va

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

Qvents
June 24, 2024

Inadequacy of Investigations, Root cause

Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations

Qvents Team
June 2, 2024

USFDA 483 to Laurus: Lapses in cleaning,

Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators

Qvents
February 18, 2024

USFDA 483 to Laurus cites deficiency in

Laurus, Visakh (India) was issued USFDA 483 with five (5) observations following USFDA inspection by

Qvents
February 14, 2024

USFDA 483 to Laurus: Lapses in investiga

Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators

Qvents
February 14, 2024

Laurus USFDA 483: Lapses in investigatio

USFDA inspected Laurus Synthesis, Visakh facility in India (FEI: 3011524794) in Dec 2023 by investigators

Qvents
January 4, 2024