Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA 483 to Eugia Polepally unit cites

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

Sichuan Deebio – 483, OAI and Warning

Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data

One more Eugia facility hit with USFDA 4

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

EUGIA India FDA483: Critical Data Integr

Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb

FDA 483 to Chinese API Manufacturer Sich

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

USFDA 483 to Laurus: Lapses in cleaning,

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

USFDA 483 to Laurus cites deficiency in

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

USFDA 483 to Laurus: Lapses in investiga

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

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)