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# MAPP on ANDA Facility Deficiency Reclassifiaction
- URL: https://www.fdaweb.com/mapp-on-anda-facility-deficiency-reclassifiaction/
- Published: 2023-06-12T12:00:00.000Z
- Updated: 2026-09-14T18:38:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154669

FDA has published a new CDER manual of policies and procedures [(MAPP) 5021.5, *Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests*](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvbWVkaWEvMTY5MzMwL2Rvd25sb2FkP3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSIsImJ1bGxldGluX2lkIjoiMjAyMzA2MTIuNzgxMjM5MzEifQ.P5T53-aGM8MYoyBMJ55Xr4C%5Fq8pMQmPyUt8KSrnvACc/s/2992177567/br/204768879483-l?ref=fdaweb.com). The document describes the policies used in the Office of Pharmaceutical Quality, the Office of Compliance, and the Office of Generic Drugs for assessing requests for reclassification of facility-based major complete response (CR) letter amendments for original ANDAs and associated prior approval supplements. “This MAPP applies to reclassification requests received as part of a single amendment that consists of both a reclassification request for facility-based deficiencies and a response to a CR letter in which the only major deficiency(ies) in the CR letter resulted from a facility inspection(s) or assessment,” the agency says. The MAPP was developed as one of the enhancements to the user fee program to make the assessment cycle more efficient.