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# FDA Issues 483 to Aurobindo API Facility
- URL: https://www.fdaweb.com/fda-issues-483-to-aurobindo-api-facility/
- Published: 2023-05-19T12:00:00.000Z
- Updated: 2026-09-14T18:33:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154496

FDA 5/19 issued Aurobindo Pharma a four-observation Form FDA-483 after concluding a five-day inspection of the firm’s Unit XIV active pharmaceutical ingredient (non-antibiotic) manufacturing facility at Paravada Industrial Area in Andhra Pradesh, India. “The observations are procedural in nature,” the company says, adding that it will respond to the agency accordingly.

In November, the agency issued Aurobindo a [separate 483](https://www.fda.gov/media/163754/download?ref=fdaweb.com) at Unit IX that cited 10 inspection observations. The issues cited were:

- out-of-specification and complaint investigations for API intermediate products were deficient;
- process validation was 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 were not validated and/or appropriately validated;
- written procedures for the cleaning and maintenance of equipment validation were deficient;
- established laboratory control mechanisms were not adequate;
- the responsibilities and procedures applicable to the quality control unit were not in writing and fully followed;
- storage of key starting materials, raw materials, and intermediates was not adequate;
- materials and intermediates were 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 were not adequate;
- computer systems used in the testing of a drug substance were not of appropriate design to facilitate operations for its intended use.