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USFDA issue form 483 to INTAS Pharma’s Moraiya Biotech Unit

Following a USFDA inspection, Intas Pharmaceuticals Limited’s biotech facility at Moraiya in Gujarat received quality warning. FDA issued a FORM 483 with 14 observations relating to good manufacturing practices.

FORM 483 is issued to a company in case of any deviations from US Food Drug and Cosmetic (FD&C) Act and related acts. Following are observations from FDA inspectors:

Other observations included, no authorized person to approve procedures, lack of SOPs for calibration of equipment, cell banks were not maintained at appropriate storage monitoring conditions and massive infestation by birds on buildings used in manufacturing, processing, packing or holding drug products.

FDA released a statement in FORM 483 stating that they observed numerous pigeons perching along the walls, dangling overhead wires and ceiling in the packing material storage warehouse. They observed pigeon faeces petri plates, dishes and box containing sterilized containers.


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