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Tag: Cleaning Validation

USFDA 483 for Glenmark Facility Highligh

USFDA 483 issued to Glenmark Pharma’s Pithampur facility (FEI: 3008565058) in India flagged critical deviations

Qvents
April 30, 2025

FDA Issues Warning Letter to Aspen Bioph

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs

Qvents
April 3, 2025

USFDA 483 Cites Piramal Pharma for Inves

Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with

Qvents Team
March 13, 2025

Contamination Control and Data Integrity

Granules India received a warning letter from the USFDA in February 2025. This was along

Qvents
March 7, 2025

FDA Issues Warning letter to Chinese API

FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing

Qvents
February 12, 2025

Investigation Docs Outside EDMS, Hold Ti

Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Srinivas Churya Jubilant Generics Roorkee facility was inspected in January

Qvents Team
November 13, 2024

Data Integrity issues, Delayed records:

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

Qvents
June 10, 2024

USFDA 483 to Torrent Pharma cites defici

Torrent’s Chhatral, Gujarat facility (FEI: 3012740315) was inspected by USFDA (Investigator Yvins Dezan) in Dec

Qvents
January 5, 2024

US Repackager Spectrum gets USFDA 483 wi

Spectrum Laboratories Inc, New Jersey, USA (FEI 2246824) was inspected by FDA investigators Sayyem H

Qvents
October 19, 2023

Warning letter / Centaur / July 2023 / C

Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing

Qvents
September 19, 2023

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