Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
Torrent Indrad, India (FEI 3005029956) was issued USFDA form 483 following inspections by USFDA inspectors Lata Mathew, Jogy
Following the USFDA inspection during 8-16 April 2019 at Torrent, Indrad, India (FEI 3005029956) by
