Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
USFDA Warning letter to Centrient India (Toansa, Punjab FEI 3004497364) in December 2022 cite method
USFDA Warning letter to Centrient India (Toansa, Punjab FEI 3004497364) in December 2022 cited inadequate
USFDA Warning letter to Centrient India (Toansa, Punjab FEI 3004497364) in December 2022 cited deficiencies in investigating
USFDA issued Warning letter to Glenmark, Goa, India facility (FEI 3004672766), cites lapses in procedure
In September 2022, USFDA issued a Warning letter to Lupin API facility at Tarapur, India
USFDA 483 for Jubilant Roorkee cited deficient review of unexplained discrepancies, OOS (out of specifications), deficient CAPAs. Jubilant
USFDA 483 to Jubilant Roorkee cited inadequate review of unexplained discrepancies, aborting dissolution testing analysis for
USFDA 483 for Jubilant Roorke cited inadequacies in investigation of equipment breakdowns, error messages, alarms.
