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# FDA Form 483 Issued to Indian API Facility
- URL: https://www.fdaweb.com/fda-form-483-issued-to-indian-api-facility/
- Published: 2017-05-15T12:00:00.000Z
- Updated: 2026-09-14T22:23:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138685

FDA has issued a [Form 483](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM557957.pdf?ref=fdaweb.com) to Badrivishal **Chemicals & Pharmaceuticals** (Maharashtra, India) related to a 8/2016 facility inspection that cited significant GMP deviations for manufactured active pharmaceutical ingredients (API). For example, FDA investigators found that the firm’s water purification system was not adequately monitored and controlled. Additionally, the inspection cited the quality unit over documents related to the API manufacturing. And, investigators found a large number of trash bags behind a building that contained torn original laboratory and production records, such as analytical test reports, water testing reports, and sample notebooks. The information on these discarded, torn documents did not match the official records. A related [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545454.htm?ref=fdaweb.com) was issued 3/2.