Warning letters, 483s, Recalls, Import Alerts, Audit observations
Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August
Potential contamination of drug products with Diethylene Glycol(DEG), Ethylene Glycol(EG) has severe consequences including fatality
Warning letter / Glenmark, Goa, India /FEI 3004672766 / MARCS-CMS 637314/ 320-23-04/ NOVEMBER 22, 2022/
USFDA Warning letter to Dupont cites inadequate evaluation of complaints, even though the Firm received several
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 3 The
Warning letter / Centrient India / MARCS-CMS 640196/ 320-23-06/ DECEMBER 07, 2022/ Observation 2 USFDA
