# FDA 483 - Aphena Pharma Solutions-Maryland LLC - May 06, 2022

Source: https://www.keypedia.com/records/483/aphena-pharma-solutions-maryland-llc/cfd0c893-ad89-4c7e-a863-f1bca8609f53

> FDA 483 for Aphena Pharma Solutions-Maryland LLC on May 06, 2022. 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: 2022-05-06
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Aphena Pharma Solutions-Maryland LLC in Easton, MD, was cited for significant deficiencies during an FDA inspection. Observations included inadequate equipment qualification for a blend tank, failures to thoroughly investigate unexplained discrepancies in batch records, and incomplete master production and control records. These issues indicate a lack of robust quality control and process validation in drug product manufacturing.

## Related Documents

- [483 - 2021-12-15](https://www.keypedia.com/records/483/aphena-pharma-solutions-maryland-llc/674e88d8-0d68-4b93-9428-5a000a4eb40d)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Sena G. Dissmeyer](https://www.keypedia.com/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)

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

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