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# FDA Hits Cipla in India with 38-page Form-483
- URL: https://www.fdaweb.com/fda-hits-cipla-in-india-with-38-page-form-483/
- Published: 2019-10-11T12:00:00.000Z
- Updated: 2026-09-15T01:55:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145230

FDA has issued a highly redacted [38-page Form-483](https://www.fda.gov/media/131707/download?ref=fdaweb.com) following an inspection at drug manufacturer Cipla in Goa, India, that concluded 9/27\. For example, the first 11 pages cited the company over its equipment and utensil cleaning. FDA also cited Cipla for its aseptic processing areas being deficient, specifically systems for maintaining equipment used to control the aseptic conditions. Additionally, FDA said that buildings used in the manufacture, processing, packing, or holding of drug products (XXX INSERT SPACE XXX)do not have the suitable size and construction to facilitate cleaning, maintenance, and proper operations. And the agency cited Cipla’s procedures for preventing microbiological contamination, saying they are not established, written and followed.