# FDA 483 - Marlex Pharmaceuticals, Inc. - August 12, 2021

Source: https://www.keypedia.com/records/483/marlex-pharmaceuticals-inc/bfb97951-bb77-4b3d-924c-adc166933f05

> FDA 483 for Marlex Pharmaceuticals, Inc. on August 12, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marlex Pharmaceuticals, Inc.
- Inspection Date: 2021-08-12
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Marlex Pharmaceuticals, Inc. in New Castle, DE, a drug repacker, relabeler, and distributor, was cited for significant deficiencies in its written procedures for handling postmarketing adverse drug experiences (PADE). The firm's standard operating procedures were found inadequate for the surveillance, receipt, record-keeping, evaluation, and reporting of adverse drug events, including issues with PADE definitions and electronic submission requirements. This indicates a critical lack of a robust pharmacovigilance system at the facility.

## Related Documents

- [483 - 2025-11-14](https://www.keypedia.com/records/483/marlex-pharmaceuticals-inc/c643837a-2c19-4566-9c91-f12b871a3a9a)

## Related Officers

- [investigator](https://www.keypedia.com/people/stephanie-c-mangigian/0cf25e6b-1e5d-4088-a13c-11483e2380ba)

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