# FDA 483 - Aphena Pharma Solutions-Maryland LLC - February 20, 2026

Source: https://www.keypedia.com/records/483/aphena-pharma-solutions-maryland-llc/b2e659a4-4309-4af6-9d5e-2a008dea4a20

> FDA 483 for Aphena Pharma Solutions-Maryland LLC on February 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aphena Pharma Solutions-Maryland LLC
- Inspection Date: 2026-02-20
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: Aphena Pharma Solutions - Maryland, LLC, a drug manufacturer in Easton, MD, was cited with three observations during an FDA inspection from February 17-20, 2026. The inspection revealed significant deficiencies in quality control, including inadequate investigations of discrepancies and out-of-specification results, and a failure to follow and maintain written procedures for batch record review and supplier evaluation. These issues indicate a lack of robust quality systems, potentially impacting product quality and integrity.

## Related Documents

- [483 - 2021-12-15](https://www.keypedia.com/records/483/aphena-pharma-solutions-maryland-llc/674e88d8-0d68-4b93-9428-5a000a4eb40d)
- [EIR - 2021-12-15](https://www.keypedia.com/records/eir/aphena-pharma-solutions-maryland-llc/17f80629-0d60-4e23-9a4e-af3779a6cbe1)
- [483 - 2022-05-06](https://www.keypedia.com/records/483/aphena-pharma-solutions-maryland-llc/cfd0c893-ad89-4c7e-a863-f1bca8609f53)
- [483 - 2026-02-20](https://www.keypedia.com/records/483/aphena-pharma-solutions-maryland-llc/f9cf7982-d7c3-4ceb-94e8-81f2da6bd523)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [Ofuje D. Daniyan](https://www.keypedia.com/people/ofuje-d-daniyan/8d7f5014-2a8a-4009-aef6-7e014df97b8b)

Company: https://www.keypedia.com/companies/aphena-pharma-solutions-maryland-llc/97893fd6-3370-41f2-95ce-17928ab057e2

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa