Mumbai: The US Food and Drug Administration (FDA) has issued a Form 483 with 14 observations relating to deviations from good manufacturing practices to Intas Pharmaceuticals Ltd’s biotech facility at Moraiya in Gujarat, according to information available on the US drug regulator’s website.
The FDA issues a Form 483 if its investigators spot any condition that in their judgement may constitute a violation of the US Food Drug and Cosmetic (FD&C) Act and related acts.
The US regulator had inspected the unit between 26 April and 10 May. The company manufactures 17 biological products.
The observations made by the FDA include deficient laboratory records, inappropriate controls over computers, insufficient written records of investigations into unexplained discrepancies in batches, lack of proper control processes to validate causes of variability in characteristics of in-process material and drug product, and lack of written procedures to prevent microbiological contamination.
Some other observations were that the quality control unit lacked responsibility to approve all procedures, there were no written procedures describing calibration of instruments, cell banks were not maintained under appropriate storage monitoring conditions and that buildings used in manufacturing, processing, packing or holding drug products were not free of infestation by birds.
“We observed numerous pigeons perching along the walls, dangling overhead wires and ceiling in the packing material storage warehouse…We observed pigeon faeces on the boxes containing the pre-sterilized empty petri plates and dishes," the FDA said in the Form 483.
An email query sent to Intas Pharma was not answered till the time of publishing this report.
The company’s Matoda facility in Gujarat, which manufactures tablets and injections, is already approved by the FDA.