Discussion forum for Pharma Quality events, Regulatory Actions

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

Centaur Warning letter : Data Integrity,

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

Qvents
July 19, 2023

Intas FDA 483 cites Manipulation of reco

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

Qvents
July 12, 2023

IPCA USFDA 483 Cite Lapses in Data Integ

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

Qvents
June 1, 2023

USFDA 483 to IPCA, Silvassa Cites Lapses

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

Qvents
May 18, 2023

Backdating and DI issues lead to Consent

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

Qvents
May 1, 2023

Intas USFDA 483 cites Data Integrity, to

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

Qvents
April 18, 2023

Centrient India Warning letter Cites Lap

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

Qvents
April 18, 2023

USFDA 483 Flags Dupont for Lapses in Avi

USFDA issues Warning letter to DuPont Nutrition USA Inc., Newark, Delaware facility (FEI 3013947845) for

Qvents Team
January 23, 2023