Tag: Data Integrity

Natco Pharma USFDA 483 Lists Eight Obser

Natco Pharma (india) Kothur facility was inspected by USFDA in October 2023. The site (FEI

USFDA 483 / UCB Farchim SA/ June 2023 /

USFDA 483 / UCB Farchim SA/ June 2023 / Gaps in Data Integrity program, lack

FDA 483 to UCB Switzerland cite gaps in

USFDA 483 issued to UCB Farchim SA, Switzerland site (FEI 3005023799) is published by FDA.

Warning letter / Centaur / July 2023 / F

The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over

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