# FDA 483 - Topiderm Inc. - March 07, 2025

Source: https://www.globalkeysolutions.net/records/483/topiderm-inc/6dfe2b49-0d6d-4068-919a-4e90ae57e61c

> FDA 483 for Topiderm Inc. on March 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Topiderm Inc.
- Inspection Date: 2025-03-07
- Product Type: drugs
- Office Name: New York District Office
- Summary: Topiderm Inc. in Amityville, NY, was cited for significant deficiencies during an FDA inspection, primarily concerning manufacturing equipment and quality control procedures. The firm failed to qualify manufacturing equipment used for drug products distributed in the US market. Additionally, the quality control unit did not adhere to multiple written procedures, including those for customer complaint handling, change control, laboratory logbook documentation, and good documentation practices, with instances of overwritten data.

## Related Officers

- [Ogechi C. Nna](https://www.globalkeysolutions.net/people/ogechi-c-nna/59452184-8197-4ba6-bf1d-78a7e003ef2c)

Company: https://www.globalkeysolutions.net/companies/topiderm-inc/77f7d7cd-dcab-4eaf-9e6c-9345561eb6ea

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d