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# 10 Observations in Aurobindo Unit FDA-483
- URL: https://www.fdaweb.com/10-observations-in-aurobindo-unit-fda-483/
- Published: 2022-12-08T12:00:00.000Z
- Updated: 2026-09-14T18:09:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153350

FDA has released the form FDA-483 issued following an 11/10-11/18 inspection at the Aurobindo Pharma Unit IX active pharmaceutical ingredient (API) intermediate manufacturing facility in Telangana, India. The form’s 10 inspection observations were:

- out-of-specification and complaint investigations for API intermediate products are deficient;
- process validation is deficient to demonstrate that the firm’s manufacturing process can reproducibly manufacture an API intermediate to ensure that predetermined quality attributes are met;
- analytical test methods and cleaning analytical methods are not validated and/or appropriately validated;
- written procedures for the cleaning and maintenance of equipment validation are deficient;
- established laboratory control mechanisms are not adequate;
- the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed;
- storage of key starting materials, raw materials, and intermediates is not adequate;
- materials and intermediates are not always reevaluated, as appropriate, to determine their suitability for use after an established retest date;
- schedules and procedures established for the preventive maintenance of equipment are not adequate;
- computer systems used in the testing of a drug substance are not of appropriate design to facilitate operations for its intended use.