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# Indoco Remedies FDA-483
- URL: https://www.fdaweb.com/indoco-remedies-fda-483/
- Published: 2019-02-13T12:00:00.000Z
- Updated: 2026-09-15T01:03:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143371

FDA has released the FDA-483 issued following a 1/17-1/25 inspection at Indoco Remedies Limited (Plant 1), a Goa, India, tablet manufacturer. The six inspection [observations](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM631226.pdf?ref=fdaweb.com) were: 

- failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failure of laboratory records to include complete data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards;
- failure of batch production and control records to include complete information relating to production and control of each batch;
- failure to describe procedures for the preparation of master production and control records in a written procedure;
- failure of laboratory controls to include establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failure of written procedures for cleaning and maintenance to include description in sufficient detail of methods, equipment, and materials used.