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# 4 Observations on Micro Labs ’483
- URL: https://www.fdaweb.com/4-observations-on-micro-labs-483/
- Published: 2026-03-25T12:00:00.000Z
- Updated: 2026-09-14T13:36:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160875

FDA has released the form FDA-483 with four observations from a 1/30-2/7/2025 inspection at the Micro Labs finished drug products manufacturing facility in Bengaluru, Karnataka, India. The specific observations were:

- failure to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
- failure of laboratory controls to include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, quality, and purity;
- failure to record and justify deviations from written test procedures and laboratory mechanisms; and
- failure to clean and maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product.