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# 3 Observations on Aurobindo FDA-483
- URL: https://www.fdaweb.com/3-observations-on-aurobindo-fda-483/
- Published: 2022-09-14T12:00:00.000Z
- Updated: 2026-09-14T17:59:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152738

FDA has released the form FDA-483 issued following a 7/25-8/2 inspection at the Aurobindo Pharma active pharmaceutical ingredient manufacturing facility in Andhra Pradesh, India. The observations were:

- procedures for the cleaning and maintenance of equipment are deficient regarding the removal or obliteration of the previous batch identification;
- failing to thoroughly investigate any unexplained discrepancy whether or not the batch has been already distributed; and
- failing to fully follow the responsibilities and procedures applicable to the quality control unit.