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# 6 Observations in Aurobindo Inspection
- URL: https://www.fdaweb.com/6-observations-in-aurobindo-inspection/
- Published: 2022-05-12T12:00:00.000Z
- Updated: 2026-09-14T17:44:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151807

India’s troubled Aurobindo Pharma says a 5/2-5/10 FDA inspection at its Unit VII oral drug manufacturing facility in Jedcherla, Hyderabad, resulted in an FDA-483 with six observations.In a [submission](https://www.bseindia.com/xml-data/corpfiling/AttachLive/00a378ba-3b1b-4582-b208-a3a73d222a44.pdf?ref=fdaweb.com) to the National Stock Exchange of India, Aurobindo says it will respond to FDA within the stipulated timeline and will work closely with the agency to close the observations.

Earlier this year, a 1/12 [Warning Letter](https://www.fdaweb.com/cgmp-deviations-at-aurobindo-facility/) cited significant deviations from current good manufacturing practice regulations for active pharmaceutical ingredients at the firm’s manufacturing facility in Doultabad, Telangana, India. And a 1/20 [Warning Letter](https://www.fdaweb.com/aurobino-pharma-gets-2nd-warning-letter-in-15-months/) listed GMP deficiencies at its Hyderabad-based Unit 1 active pharmaceutical ingredient manufacturing facility.