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# 7 Observations on Aurobindo FDA-483
- URL: https://www.fdaweb.com/7-observations-on-aurobindo-fda-483/
- Published: 2019-10-10T12:00:00.000Z
- Updated: 2026-09-15T01:55:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145212

There are seven inspection observations on the FDA-483 released by the agency following a 9/19-9/27 inspection at the Aurobindo finished drug manufacturing facility in Telangana, India. The observations were: 

- failing to thoroughly review any unexplained discrepancy and failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been already distributed;
- failing to have written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- failing to establish control procedures for those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
- failure of laboratory records to include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and standards;
- failing to fully follow responsibilities and procedures applicable to the quality control unit;
- failing to clean utensils and equipment at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product; and
- failing to follow written production and process control procedures in the execution of production and process control functions.