# FDA 483 - SigmaPharm Laboratories LLC - December 17, 2025

Source: https://www.globalkeysolutions.net/records/483/sigmapharm-laboratories-llc/818e7c64-f462-402d-b9d1-f97cfbf1bc74

> FDA 483 for SigmaPharm Laboratories LLC on December 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SigmaPharm Laboratories LLC
- Inspection Date: 2025-12-17
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: During an FDA inspection, SigmaPharm Laboratories LLC, a non-sterile finished drug manufacturer in Bensalem, PA, was cited for inadequate investigation procedures. The firm failed to expand the scope of an investigation into foreign plastic fragments found in a rejected drug lot. This lapse meant that a retrospective review of other drug products potentially affected by the same non-procedural modification was not conducted, indicating a significant quality control concern.

## Related Officers

- [Ofuje D. Daniyan](https://www.globalkeysolutions.net/people/ofuje-d-daniyan/8d7f5014-2a8a-4009-aef6-7e014df97b8b)

Company: https://www.globalkeysolutions.net/companies/sigmapharm-laboratories-llc/f300f462-6d27-47a8-842b-031dbdeed07b

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