Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 1 USFDA
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
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
