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# Natco Pharma Inspection Report
- URL: https://www.fdaweb.com/natco-pharma-inspection-report/
- Published: 2017-02-02T12:00:00.000Z
- Updated: 2026-09-14T22:04:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137890

FDA has released the FDA-483 issued at the conclusion of a [1/16-1/24 inspection ](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM539386.pdf?ref=fdaweb.com)at Natco Pharma, Telangana, India. Specific inspection observations included: 

- failing to fully follow responsibilities and procedures applicable to the quality control unit;
- failing to follow the written stability testing program;
- failing to have laboratory controls include establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to submit a Field Alert Report within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be applied to another article;
- failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and
- separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of drug products after release.