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# Global Calcium FDA-483 Has 6 Observations
- URL: https://www.fdaweb.com/global-calcium-fda-483-has-6-observations/
- Published: 2026-04-23T12:00:00.000Z
- Updated: 2026-09-14T13:37:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161029

FDA has released the form FDA-483, with six observations from a 1/27-2/3 inspection at Global Calcium Pvt. Ltd., an active pharmaceutical ingredient manufacturer in Hosur, India. The specific inspection observations were:

- failure of laboratory records to include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and standards;
- failure to follow established sampling plans and test procedures;
- failure of laboratory controls to include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to established specifications;
- cleaning procedures are not appropriate or reproducible to prevent contamination that would alter the safety, identity, strength, quality, or purity of the finished drug substances;
- failure to establish and maintain an effective Quality System to prevent Data Integrity breaches and to ensure employees can report GMP-related concerns without fear of identification or retaliation; and
- failure to fully follow the responsibilities of the Quality Unit.