# FDA 483 - Jubilant Cadista Pharmaceuticals, Inc. - February 28, 2020

Source: https://www.keypedia.com/records/483/jubilant-cadista-pharmaceuticals-inc/fdf3097d-13b9-416c-ba5e-0b1cc12c2ece

> FDA 483 for Jubilant Cadista Pharmaceuticals, Inc. on February 28, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jubilant Cadista Pharmaceuticals, Inc.
- Inspection Date: 2020-02-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Jubilant Cadista Pharmaceuticals, Inc. in Salisbury, MD, revealed significant deficiencies in manufacturing practices, complaint handling, and regulatory reporting. Observations included inadequate procedures to prevent microbial contamination during packaging, failure to properly investigate product complaints, and delayed submission of field alert reports for serious product defects. These issues suggest a lack of control over critical quality processes.

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Company: https://www.keypedia.com/companies/jubilant-cadista-pharmaceuticals-inc/bf3fdb52-1211-4c3c-8e41-659d9e4e13f9

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e