A blue binder containing batch records for US-bound drug products was among the unreviewed documents, some dated as recently as a week before the facility inspection, that a US Food and Drug Administration investigator discovered in a 55-gallon drum in a Puducherry, India, drug manufacturing plant’s scrap yard.
The investigator saw other good manufacturing practice records during a 28 January to 5 February 2019 inspection of the Strides Pharma Inc. plant, color-coded to show they were...