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# 8 Inspection Observations at Indoco Remedies
- URL: https://www.fdaweb.com/8-inspection-observations-at-indoco-remedies/
- Published: 2018-02-23T12:00:00.000Z
- Updated: 2026-09-14T23:25:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140832

The FDA-483 issued following a 1/15-1/19 FDA inspection at Indoco Remedies, Goa, India, lists eight inspection [observations](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM597054.pdf?ref=fdaweb.com): 

- laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards and electronic records do not meet requirements to ensure that they are trustworthy, reliable, and generally equivalent to paper records;
- laboratory controls do not include establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
- the written stability program for drug products does not include test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability;
- reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration;
- responsibilities and procedures applicable to the quality control unit are not in writing and fully followed;
- batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, packing, or holding;
- there is no documentation of the examination and review of labels and labeling for conformity with established specifications; and
- equipment used in the manufacture, processing, packing, or holding or drug products is not of appropriate design to facilitate operations for its intended use.