# FDA 483 - Ophtapharm AG - February 28, 2020

Source: https://www.globalkeysolutions.net/records/483/ophtapharm-ag/10f6230a-227e-4b14-852b-d8807f88e27b

> FDA 483 for Ophtapharm AG on February 28, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ophtapharm AG
- Inspection Date: 2020-02-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Akorn AG in Hettlingen, Switzerland, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate training for supervisory personnel, failure to properly manage changes to written procedures, and a lack of yield determination and investigation into process variations. These issues indicate a lack of robust quality systems impacting drug product safety, identity, strength, quality, and purity.

## Related Documents

- [483 - 2017-12-12](https://www.globalkeysolutions.net/records/483/ophtapharm-ag/abd01715-ac17-4651-8e5e-633204787534)

## Related Officers

- [Russell J. Glapion](https://www.globalkeysolutions.net/people/russell-j-glapion/54dd6274-563a-44fe-8016-2ebd700be7a0)

Company: https://www.globalkeysolutions.net/companies/ophtapharm-ag/bf7065a3-51c2-4dd4-bcac-c2e0ab295ec4

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1