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# 5 Observations in Glenmark Inspection
- URL: https://www.fdaweb.com/5-observations-in-glenmark-inspection/
- Published: 2018-06-06T12:00:00.000Z
- Updated: 2026-09-15T00:10:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141620

FDA has released the FDA-483 with five observations issued following a 5/14-5/24 inspection at Glenmark Pharmaceuticals, a Madhya Pradesh, India, finished oral solid dose manufacturer. The specific [observations](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM609965.pdf?ref=fdaweb.com) were:

- failing to establish and document the accuracy, specificity, and reproducibility of test methods;
- failing to have laboratory controls include establishment of scientifically sound and appropriate sampling plans designed to assure that products conform to appropriate standards of identity, strength, quality, and purity;
- failing to thoroughly review any unexplained discrepancy, whether or not a batch has been already distributed;
- failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records are instituted only by authorized personnel; and
- failing to fully follow the responsibilities and procedures applicable to the quality control unit.