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# 5 Observations in Cipla FDA-483
- URL: https://www.fdaweb.com/5-observations-in-cipla-fda-483/
- Published: 2022-09-21T12:00:00.000Z
- Updated: 2026-09-14T18:00:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152784

FDA has released the form FDA-483 issued following an 8/16-8/26 inspection at the Cipla drug manufacturing facility in Goa, India. The five inspection observations were:

- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting to produce aseptic conditions;
- appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel; and
- the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.