A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. In the letter to Mumbai-based company, the USFDA pointed out drug firm's failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilisation processes.
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» USFDA pulls up Sun Pharma for lapses in Halol plant
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