Aurobindo’s AuroLife Warned By FDA Over Leaky Facilities

Warning Letter Notes Multiple Incidences Of Water Leakage At New Jersey Plant

 
• By Akriti Seth

After issuing Form 483 observations, the FDA has issued a warning letter to Aurobindo’s AuroLife linked to its manufacturing facility in New Jersey. The agency has warned that if the violations are not corrected promptly, it will take further action to ensure quality control.

ceiling_leakage
Leaky ceilings were among the deficiencies seen by the FDA at Aurolife’s manufacturing facility in New Jersey • Source: Shutterstock

Aurobindo’s AuroLife Pharma has received a warning letter from the US Food and Drug Administration for its drug manufacturing facility in New Jersey, mainly based on the company’s failure to follow procedures for cleaning and maintenance of equipment and failure to maintain buildings used for manufacturing in a good state of repair, causing multiple incidences of water leakage from the ceiling of its encapsulation room and packaging area.

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