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483
•Mylan Laboratories Limited•January 18, 2019

Mylan Laboratories Limited – FDA 483, Jan 18, 2019

Record Details

Mylan Laboratories Limited in Sinnar, India, received a Form 483 with two observations during an inspection from January 14-18, 2019. The inspection revealed deficiencies in laboratory record-keeping for microbiological samples and significant issues with employee training. These observations indicate a need for improved quality control and personnel training practices.

Company
Mylan Laboratories Limited
Inspection date
January 18, 2019
Product type
drugs
Office
Office of Biological Products Operations - Division I
Person
  • Kellia N. Hicks (Investigator)
View Company Profile

ID · 7c112c60-9ef9-405f-9cdf-2e08ef2210f7

Other documents for Mylan Laboratories Limited
  • 483 - 2026-05-15May 15, 2026
  • 483 - 2024-05-24May 24, 2024
  • 483 - 2020-02-07February 7, 2020
  • 483 - 2018-04-12April 12, 2018
  • 483 - 2016-09-14September 14, 2016

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