Warning letters, 483s, Recalls, Import Alerts, Audit observations
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.
Strides in July 2022 recalled from US market 1032 bottles of Prednisolone USP 20mg tablets for
USFDA Warning letter to Mylan in 2020 cited inadequacy of cleaning, cleaning procedures, risk assessment of
USFDA Warning letter to Mylan in 2020 cited inadequate procedures to monitor and control recovered
An USFDA 483 (2019) to Torrent cites deficient Process validation practices and procedures. The observations
