Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA 483 to Jubilant : Data Integrity con

USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd,

USFDA 483 to Eugia Polepally unit cites

USFDA had inspected Aurobindo’s Eugia SEZ Pvt Ltd facility at Polepally, Telengana in India in

One more Eugia facility hit with USFDA 4

Aurobindo’s Eugia SEZ Pvt. Ltd at Polepally Village, Mehaboob Nagar, Telengana was inspected by USFDA

FDA 483 to Chinese API Manufacturer Sich

The USFDA 483 issued to Sichuan Deebio Pharmaceutical Co. Ltd cite critical data integrity observations

USFDA483 to Aurobindo’s Eugia US Site

USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance

FDA 483 to Dr.Reddy’s cites discrepanc

FDA inspected the Drug Testing Establishment of DRL (Dr.Reddy’s Laboratories) at Bachupally, Telengana India (FEI:3009483004)

USFDA 483 to Torrent Pharma cites defici

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

Laurus USFDA 483: Lapses in investigatio

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

Warning letter to Intas, Ahmedabad after

Intas facility at Matoda, Sanand in India (FEI 3004011473) was inspected by FDA investigators Jose E

USFDA 483 to Catalent Indiana Cites Poor

Catalent USFDA 483 /Bloomington (FEI :3005949964)/ Inspection Dates: May 4-12, 2023 / Inspectors: Wayne Scifert,