Micro Orgo Chem

Warning LetterOpen

Mr. Vinod Ranka Managing Director Micro Orgo Chem 57, C-1B, LIC sector, GIDC Vapi 396195 Gujarat India info@mocind.comFEI 3004513977Issued Dec 3, 2024Center for Drug Evaluation and Research (CDER)

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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 3004513977.

Violations5

Issue DateDec 3, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Micro Orgo Chem
Location: Mr. Vinod Ranka Managing Director Micro Orgo Chem 57, C-1B, LIC sector, GIDC Vapi 396195 Gujarat India info@mocind.com
FEI Number: 3004513977
Country: India
Issue Date: December 03, 2024
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Micro Orgo Chem, an active pharmaceutical ingredient (API) manufacturer in India, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their APIs adulterated. The FDA inspection (April 11-18, 2024) identified critical failures including inadequate validation of cleaning procedures for non-dedicated equipment, failure to collect and test required rinse and swab samples, and poor equipment maintenance creating cross-contamination risks. The company acknowledged that sanitary conditions in manufacturing and laboratory areas were not maintained to required standards and committed to a voluntary recall of all APIs shipped to the U.S. market.

Micro Orgo Chem FDA Warning Letter, December 3, 2024