Typically the FDA reviews the submitted ANDA as well as the GMP facilities Inspections where (1)the APIs will be received, (2) The GMP facilities where the ANDA will be manufactured, (3) the GMP facilities from where the finished ANDA will be stored and shipped from as well as (4) $ELTP SOPs for the details.
In $ELTP's Percocet case the FDA CR report was for "A MINOR AMENDMENT" and would have resulted from the Pre-Approval Inspections that Nasrat Hakim referred to at the last CC.
From the 8-K
Quote:
Elite Pharmaceuticals, Inc. ("Elite" or the “Company") received a Complete Response (CR) from the U.S. Food & Drug Administration (FDA) for its Percocet generic ANDA application. The FDA stated that the response to “the CR letter will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR.” Elite intends to submit a “MINOR AMENDMENT” shortly to address the deficiencies listed. The Percocet generic ANDA submission was received for review by the FDA in November 2016.
Percocet is an Oxycodone Hydrochloride with Acetaminophen combination. Since $ELTP is already receiving Oxycodone it could be that The MINOR AMENDMENT, is possibly related to the API acetaminophen handling and storage, which would be new for $ELTP.
It is req'd that the $ELTP correction be received by the FDA in seven days for the approval process. IMO $ELTP has already sent its official amendment detail actions to the FDA. IMO Percocet FDA approval will now follow.
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