# FDA 483 - Lannett Company Inc. - October 21, 2022

Source: https://www.keypedia.com/records/483/lannett-company-inc/11ee4cf9-705f-4c46-aaf5-48b305695a7d

> FDA 483 for Lannett Company Inc. on October 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lannett Company Inc.
- Inspection Date: 2022-10-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Lannett Company Inc. in Seymour, IN, a pharmaceutical manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate laboratory records with unreviewed deleted data and modifiable system dates, a quality control unit failing to close deviations within established timeframes, and batch production records lacking specific identification for in-process materials. These issues indicate a lack of control over data integrity and manufacturing processes.

## Related Documents

- [483 - 2018-02-02](https://www.keypedia.com/records/483/lannett-company-inc/dda9f9c8-08a9-44ba-988e-38216efbcd36)

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [S. PowerCramer](https://www.keypedia.com/people/s-powercramer/9dc45200-9305-4fed-8686-19d18a33a787)
- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)

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