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# Mfr. Deficiencies Hamper 1st Cycle ANDA Reviews
- URL: https://www.fdaweb.com/mfr-deficiencies-hamper-1st-cycle-anda-reviews/
- Published: 2022-09-29T12:00:00.000Z
- Updated: 2026-09-14T18:01:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152860

FDA says manufacturing-related deficiencies contribute significantly to a low rate of ANDA approvals for modified-release tablet products during the first review cycle. Writing in the 9/28 issue of the [journal *AAPS PharmSciTech*](https://pubmed.ncbi.nlm.nih.gov/36168006/?ref=fdaweb.com), CDER researchers said only 12% of such products were approved first cycle between fiscal years 2017 to 2019\. Of the 88% (169 ANDAs) that received a complete response letter, 91% were found inadequate for multiple review disciplines.

In their [analysis](http://www.fdaweb.com/download.php?file=mfr%5Fdef%5Fmr%5Ftabs.pdf), the researchers found that 1,345 drug product manufacturing process-related deficiencies were issued to 184 ANDAs during the first review cycle. “The top deficiencies cited reasons include facilities are out of compliance/not ready to commercialize/not ready for inspection; critical process parameter (CPP) ranges are not proposed*/*proposed CPP ranges are too wide and/or not supported by studied range and no in-process controls (IPCs) are proposed*/*proposed IPCs acceptance criteria (limits) are too wide and/or not supported by observed data etc.,” they wrote.

The researchers concluded that avoiding common drug product manufacturing deficiencies may reduce the need for issuing manufacturing-related deficiencies in information requests, discipline review letters, and complete response letters for modified-release tablet ANDAs.