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# FDA Hits Torrent Pharma with Form 483 After Inspection
- URL: https://www.fdaweb.com/fda-hits-torrent-pharma-with-form-483-after-inspection/
- Published: 2017-05-12T12:00:00.000Z
- Updated: 2026-09-14T22:23:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138678

FDA has issued Torrent Pharmaceuticals a four-item [Form 483 ](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM557960.pdf?ref=fdaweb.com)following an inspection last month at the firm’s drug manufacturing facility in Indrad, Gujarat, India. The observations are related to deficiencies with procedures and documentation practices. For example, the agency cited Torrent on its change control records that were not closed in a timely manner. Additionally, the inspection found that out-of-specification results were not thoroughly investigated.