Ms. Aditi Kare Panandikar
Managing Director
Indoco Remedies Limited
Indoco House, 166, C.S.T Road
Kalina Santacruz (E)
Mumbai 400098
IndiaFEI 3005124189Issued Dec 16, 2024Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005124189.
Violations6
Issue DateDec 16, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Indoco Remedies Limited
Location
Ms. Aditi Kare Panandikar
Managing Director
Indoco Remedies Limited
Indoco House, 166, C.S.T Road
Kalina Santacruz (E)
Mumbai 400098
India
FEI Number
3005124189
Country
India
Issue Date
December 16, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Indoco Remedies Limited's drug manufacturing facility in Goa, India failed to maintain Current Good Manufacturing Practice (CGMP) standards, resulting in adulterated finished pharmaceutical products. During a July 2024 inspection, investigators identified critical deficiencies in microbiological testing controls, including non-viable dark particles contaminating culture plates and filters, inconsistent media plate preparation, and failure to properly document and justify deviations from required laboratory control mechanisms. These quality control failures created significant risk that microbiological contaminants could go undetected in finished drug products released to market.
Indoco Remedies Limited FDA Warning Letter, December 16, 2024