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483
•Lannett Company LLC•February 2, 2018

Lannett Company LLC – FDA 483, Feb 2, 2018

Record Details

Bennett Company Inc. in Seymour, IN, was inspected from January 29 to February 2, 2018, revealing two significant observations. The inspection found deficiencies in the firm's quality control unit procedures, including issues with deviation reporting, product complaint handling, and laboratory data recording. Additionally, the firm's batch production and control records were found to be inadequate, specifically lacking proper documentation for desiccant handling during packaging operations.

Company
Lannett Company LLC
Inspection date
February 2, 2018
Product type
drugs
Office
Division of Pharmaceutical Quality Operations III
People
  • Emilie E. Kahn (Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality)
  • Emily J. Orban
View Company Profile

ID · dda9f9c8-08a9-44ba-988e-38216efbcd36

Other documents for Lannett Company LLC
  • 483 - 2026-08-21August 21, 2026
  • 483 - 2022-10-21October 21, 2022
  • EIR - 2018-07-23July 23, 2018

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