Tag: Data Integrity

USFDA Issues Warning Letter to Global Ca

Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in

FDA Warning Letter to Viatris: Concerns

FDA has published the Warning Letter issued to the Viatris Pithampur facility in December 2024. This Warning

USFDA Flags Major cGMP Deviations at Une

New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch

Data Integrity, Cleaning Issues: Granule

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

Intas Recall Cisplatin Injection For Imp

Accord Healthcare Inc, US is recalling one lot of Cisplatin injection due to failed impurities.

Deficiencies That Lead to Officiation Ac

Five different facilities of Eugia across India and US were inspected by USFDA between December

Global Calcium USFDA 483: Critical Data

With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary The USFDA inspection

Zydus Jarod Facility Classified OAI

Zydus Jarod facility (FEI 3013712903) is classified OAI by USFDA in July 2024. The USFDA

Data Integrity issues, Delayed records:

USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site

Inadequacy of Investigations, Root cause

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