Tag: Data Integrity

Four Indian Pharma sites issued Warning

Related Links Warning letter Intas Warning letter Centaur Warning letter Medgel Warning letter Baxter Intas

Warning letter to Intas, Ahmedabad after

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

USFDA 483 / Intas / May 2023 /Manipulati

USFDA483 to Intas cites manipulated visual inspection reports; failure to characterise particles observed in injection

Centaur Warning letter : Data Integrity,

Centaur Pharmaceuticals, India issued Warning letter by USFDA. The Warning letter dated 5 June 2023

Intas FDA 483 cites Manipulation of reco

FDA published the USFDA483 issued to Intas site (FEI 3003157498) in Ahmedabad, India after inspection

IPCA USFDA 483 Cite Lapses in Data Integ

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/ USFDA Investigators: Rajiv Srivastava, Kellia

USFDA 483 to IPCA, Silvassa Cites Lapses

FDA has published the USFDA form 483 issued to Ipca Laboratories Ltd following inspection at

Backdating and DI issues lead to Consent

USFDA 483 / Sun Pharma, Mohali, India / FEI 3002807979 / USFDA Investigators: Justin A

Intas USFDA 483 cites Data Integrity, to

USFDA Inspection of Intas, Matoda, Sanand facility in India (FEI 3004011473); from 22 November 2022 to

Centrient India Warning letter Cites Lap

Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 1 USFDA