# FDA 483 - Aphena Pharma Solutions-Maryland LLC - December 15, 2021

Source: https://www.globalkeysolutions.net/records/483/aphena-pharma-solutions-maryland-llc/674e88d8-0d68-4b93-9428-5a000a4eb40d

> FDA 483 for Aphena Pharma Solutions-Maryland LLC on December 15, 2021. 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: 2021-12-15
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Aphena Pharma Solutions-Maryland LLC was inspected from December 7-15, 2021, revealing significant deficiencies in quality control, manufacturing, and facility maintenance. The inspection found failures in OOS investigations, inadequate laboratory controls, improper storage conditions, and unsanitized equipment, indicating a lack of adherence to cGMP regulations.

## Related Documents

- [483 - 2022-05-06](https://www.globalkeysolutions.net/records/483/aphena-pharma-solutions-maryland-llc/cfd0c893-ad89-4c7e-a863-f1bca8609f53)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/juliana-m-badalucco/3fee9b67-1209-4f7e-8108-bd835251f6c9)
- [Roseline N. Boateng](https://www.globalkeysolutions.net/people/roseline-n-boateng/81c4fa2a-1f0b-4e13-ba45-39ca7a07d3b3)
- [Mindy M. Chou](https://www.globalkeysolutions.net/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

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

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64