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# FDA Hits Troubled Aurobindo with Form-483
- URL: https://www.fdaweb.com/fda-hits-troubled-aurobindo-with-form-483/
- Published: 2019-10-08T12:00:00.000Z
- Updated: 2026-09-15T01:55:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145191

FDA has issued Aurobindo a Form-483 after an inspection last month at the firm’s Unit 7 manufacturing facility in Telangana, India. It appears the agency has stepped up enforcement at the company following earlier inspections that uncovered [data integrity ](https://www.business-standard.com/article/pti-stories/fda-points-out-data-integrity-lapses-at-aurobindo-pharma-unit-119061300684%5F1.html?ref=fdaweb.com)and other concerns. Aurobindo says the September GMP inspection ended 9/27 with seven observations, adding that it believed none was related to data integrity. The company says it is confident that it can address the issues within the stipulated timeline.

Increased scrutiny with Aurobindo is also likely after multiple inspections cited similar GMP observations at different facilities in the company’s network. A June [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharma-limited-577033-06202019?ref=fdaweb.com) said that “repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate.” The letter also told Aurobindo to schedule a regulatory meeting to discuss CGMP compliance at three of its units.