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# Laurus Synthesis FDA-483
- URL: https://www.fdaweb.com/laurus-synthesis-fda-483/
- Published: 2024-01-03T12:00:00.000Z
- Updated: 2026-09-14T14:19:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156067

FDA has released the form FDA-483 issued following a 12/4-12/12/2023 inspection at Laurus Synthesis Private Limited in Andhra Pradesh, India. The five inspection [observations](fda.gov/media/175136/download?attachment) were:

- failing to adequately investigate unexpected occurrences;
- sampling plans for intermediates are inadequate;
- failing to maintain, clean, and store equipment in a manner to prevent contamination;
- batch production records do not contain complete information related to the production and control of the batch;
- failing to adequately control issuing documents.