Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA Warning letter to Dupont cites inadequate OOS investigations, Root cause and CAPA, Impact evaluation. The warning letter
USFDA Warning letter to Dupont cites failure to ensure test methods are suitable, use of Non
USFDA Warning letter to Dupont cites inadequate change management program. The warning letter to Dupont Nutrition USA in
USFDA Warning letter to Dupont, USA cites inadequate laboratory controls, integrity of data and quality system does
Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 2 USFDA
Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 1 USFDA
USFDA Warning letter to Centrient India (Toansa, Punjab FEI 3004497364) in December 2022 cited deficiencies in investigating
Warning letter / Glenmark, Goa, India /FEI 3004672766 / MARCS-CMS 637314/ 320-23-04/ NOVEMBER 22, 2022/
In September 2022, USFDA issued a Warning letter to Lupin API facility at Tarapur, India
USFDA483 for Jubilant Roorkee cited deficient review of unexplained discrepancies, OOS (out of specifications),  deficient CAPAs. Jubilant Generics
