# FDA 483 - Marlex Pharmaceuticals, Inc. - November 14, 2025

Source: https://www.keypedia.com/records/483/marlex-pharmaceuticals-inc/c643837a-2c19-4566-9c91-f12b871a3a9a

> FDA 483 for Marlex Pharmaceuticals, Inc. on November 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marlex Pharmaceuticals, Inc.
- Inspection Date: 2025-11-14
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Marlex Pharmaceuticals, Inc. in New Castle, DE, a drug repacker and relabeler, identified two significant observations. The firm's procedures for cleaning and maintaining packaging equipment were found to be deficient, lacking sufficient detail and adequate cleaning validation. Additionally, drug products were not stored under appropriate temperature and humidity conditions due to inadequate monitoring in the warehouse.

## Related Documents

- [483 - 2021-08-12](https://www.keypedia.com/records/483/marlex-pharmaceuticals-inc/bfb97951-bb77-4b3d-924c-adc166933f05)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [investigator](https://www.keypedia.com/people/daniel-t-lee/8147e5b2-2065-42e3-b86c-36c0231f74cc)

Company: https://www.keypedia.com/companies/marlex-pharmaceuticals-inc/0da60eaf-e48c-4cfe-9df6-f7136f19b0f5

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8