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# FDA Cites Natco Pharma After Inspection in India
- URL: https://www.fdaweb.com/fda-cites-natco-pharma-after-inspection-in-india/
- Published: 2017-01-25T12:00:00.000Z
- Updated: 2026-09-14T22:02:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137826

FDA has issued Natco Pharma Ltd. a six-item Form 483 after a 1/16-24 inspection of its pharmaceutical formulations facility in Kothur, near Hyderabad, India. In an unprecedented move by the company, it released a [redacted copy](http://natcopharma.co.in/wp-content/uploads/2015/02/Kothur-Formulation-Facility-FDA-2017.pdf?ref=fdaweb.com) of the inspection report. The company says the observations are “correctable,” and mostly related to complaint and incident investigations, stability backlog and “procedural SOP’s.”

According to the 483, the company was cited for having an inadequate quality control unit. For example, it said complaint investigations were not conducted in a timely manner. Agency investigators also said the firm’s written stability program was not followed. Additionally, the inspection found several problems related to laboratory controls.