# FDA 483 - Lannett Company Inc. - February 02, 2018

Source: https://www.keypedia.com/records/483/lannett-company-inc/dda9f9c8-08a9-44ba-988e-38216efbcd36

> FDA 483 for Lannett Company Inc. on February 02, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lannett Company Inc.
- Inspection Date: 2018-02-02
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

## Related Documents

- [483 - 2022-10-21](https://www.keypedia.com/records/483/lannett-company-inc/11ee4cf9-705f-4c46-aaf5-48b305695a7d)

## Related Officers

- [Emily J. Orban](https://www.keypedia.com/people/emily-j-orban/e0008df4-4986-413d-a943-9fafcf385021)
- [Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality](https://www.keypedia.com/people/emilie-e-kahn/fac179e5-478f-4e75-9632-40d921f44a8f)

Company: https://www.keypedia.com/companies/lannett-company-inc/d4d7f04f-0ec5-4f5a-868b-d48963202cc8

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0