FDA blasts Indian manufacturer's MD site for unclean conditions in Form 483 letter
For the first time in more than a year, the FDA has posted a Form 483, and this time a Rockville, MD plant of Indian manufacturer Jubilant Generics got the bad news.
In March, inspectors noticed leftover residue on a compression machine used for three different tablet batches, failing to prevent potential contamination. Drug residue and particles were found in the drain pipe and on the walls, and rust was found on the port of a machine used for six different drugs distributed in the US.
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