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  7. Divi's Laboratories Ltd. (Unit II)
483
•Divi's Laboratories Ltd. (Unit II)•July 19, 2024

Divi's Laboratories Ltd. (Unit II) – FDA 483, Jul 19, 2024

Record Details

An FDA inspection of Divi's Laboratories Ltd. (Unit II) in Visakhapatnam District, India, an API manufacturer, revealed a significant deficiency in their equipment cleaning procedures. The firm failed to establish adequate written procedures for cleaning equipment used in API manufacturing, specifically lacking provisions for cleaning or visually inspecting areas behind certain equipment components. This indicates a moderate severity issue related to facility and equipment control.

Company
Divi's Laboratories Ltd. (Unit II)
Inspection date
July 19, 2024
Product type
drugs
Office
Office of Biological Products Operations - Division I
People
  • Andrew Le (Regulatory Affairs Specialist)
  • Khoa Nathan V. Tran (issuing_officer)
  • David V. Ward
View Company Profile

ID · c752310d-e2c0-48fa-af91-1e0c7248a11c

Other documents for Divi's Laboratories Ltd. (Unit II)
  • 483 - 2017-09-19September 19, 2017
  • 483 - 2016-12-06December 6, 2016

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