Cipla, Ltd.November 30, 2018

FDA 483 - Cipla, Ltd. - November 30, 2018

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Record Details

An FDA inspection of Cipla, Ltd. in Kurkumbh Village, India, from November 26-30, 2018, revealed significant deficiencies in the firm's manufacturing practices. Observations included a failure to follow written procedures for equipment cleaning validation and a pervasive lack of raw data evidence for critical production and process control parameters. These issues indicate serious concerns regarding data integrity and adherence to established quality standards.

Company: Cipla, Ltd.
Inspection Date: November 30, 2018
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Rozelle G. Smith (investigator)

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ID · 073508e0-bb26-49d8-a957-16fbe67ca9f6