Mr. Sandeep Gokaraju
Owner and Director
Tyche Industries Ltd
6-223, Sarpavaram (V)
Kakinada 533005
Andhra Pradesh
India
sandeepraju@tycheindustries.netFEI 3004790309Issued Feb 6, 2025Center 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 3004790309.
Violations4
Issue DateFeb 6, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Tyche Industries Ltd
Location
Mr. Sandeep Gokaraju
Owner and Director
Tyche Industries Ltd
6-223, Sarpavaram (V)
Kakinada 533005
Andhra Pradesh
India
sandeepraju@tycheindustries.net
FEI Number
3004790309
Country
India
Issue Date
February 06, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Tyche Industries Ltd, an active pharmaceutical ingredient manufacturer in India, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered its APIs adulterated. FDA inspectors documented serious data integrity failures, including operators falsifying temperature records for a drying oven during batch manufacture and quality assurance staff backdating calculation sheets provided to investigators. The company's response was deemed inadequate, proposing a ten-month timeline to address critical data integrity gaps despite the severity of the documented misconduct.
Tyche Industries Ltd FDA Warning Letter, February 6, 2025
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