Tag: Investigation Deficiencies

IPCA USFDA 483 Highlight Criticality of

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

Lupin USFDA 483 cites deficient failure

USFDA 483 to Lupin Pithampur in Mar 2023 (Inspectors Eileen A Liu, Yvins Dezan) cites

Lupin USFDA 483 Cites Lapses in OOS Inve

USFDA 483 to Lupin Pithampur in Mar 2023 (Inspectors Eileen A Liu, Yvins Dezan) cites deficiencies

FDA Warning Letter to Glenmark Cites Lap

Warning letter / Glenmark, Goa, India /FEI 3004672766 / MARCS-CMS 637314/ 320-23-04/ NOVEMBER 22, 2022/

USFDA 483 to Jubilant cites poor OOS Inv

USFDA483 for Jubilant Roorkee cited deficient review of unexplained discrepancies, OOS (out of specifications),  deficient CAPAs. Jubilant Generics

Jubilant USFDA 483 – Lapses QC equipme

USFDA 483 for Jubilant Roorke cited inadequacies in investigation of equipment breakdowns, error messages, alarms.

USFDA 483 Flags Dupont for Lapses in Avi

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