Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA had inspected Aurobindo’s Eugia SEZ Pvt Ltd facility at Polepally, Telengana in India in
Aurobindo’s Eugia SEZ Pvt. Ltd at Polepally Village, Mehaboob Nagar, Telengana was inspected by USFDA
The USFDA 483 issued to Sichuan Deebio Pharmaceutical Co. Ltd cite critical data integrity observations
USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance
FDA inspected the Drug Testing Establishment of DRL (Dr.Reddy’s Laboratories) at Bachupally, Telengana India (FEI:3009483004)
Torrent’s Chhatral, Gujarat facility (FEI: 3012740315) was inspected by USFDA (Investigator Yvins Dezan) in Dec
USFDA inspected Laurus Synthesis, Visakh facility in India (FEI: 3011524794) in Dec 2023 by investigators
Intas facility at Matoda, Sanand in India (FEIÂ 3004011473) was inspected by FDA investigators Jose E
FDA published the USFDA483 issued to Intas site (FEI 3003157498) in Ahmedabad, India after inspection
IPCA Ratlam (India) was issued USFDA 483 with 11 observations after inspection in June 2023
