FDA ships Form 483 to generic drug giant Dr. Reddy’s due to equipment issues, other observations
The FDA has issued a Form 483 letter to Indian generic drug giant Dr. Reddy’s Laboratories, after the agency found potentially contaminated drugs during an eight-day inspection from Oct. 19 at its site in Telangana, India.
The 23-page letter cites nine observations, including poorly-cleaned equipment and dented machinery, causing leakages and liquid spillages.
Residues of previously manufactured drug products were found in manufacturing equipment, leading to potential contamination. The manufacturers’ written specifications for testing aerobic microbial, yeast and mold counts for drug products were also “deficient,” leading to discrepancies in colony counts, according to FDA inspectors.
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