Indoco Remedies stresses that Form 483s are not data integrity related
The drug and API manufacturer revealed US Food and Drug Administration (FDA) inspectors had issued it with six Form 483s in a filing on the Bombay Stock Exchange BSE) last week.
According to the document, an FDA team visited its Goa II facility on August 31 in an inspection triggered by the filing of ANDAs for an unnamed injectable drug or drugs in the US.
In the filing Indoco stated that “at the end of the inspection, six 483s were issued. All the observations (483s) are correctable and the Company expects to complete the corrective and preventive actions within a period of 30 days.”
The Mumbai firm also made clear that none of the 483s “are related to Data Integrity.”
The FDA has criticized a number of Indian drug and API firms for their management of manufacturing and quality data in recent months.
Indoco did not respond to a request for comment.
The Goa II facility was approved for the manufacture of solid dose drugs by the FDA in May.
