# FDA 483 - Hercon Pharmaceuticals, LLC - April 05, 2019

Source: https://www.globalkeysolutions.net/records/483/hercon-pharmaceuticals-llc/a9723ffb-bc3d-49aa-93e2-1d27b498ae21

> FDA 483 for Hercon Pharmaceuticals, LLC on April 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hercon Pharmaceuticals, LLC
- Inspection Date: 2019-04-05
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Hercon Pharmaceuticals, LLC in Emigsville, PA, was inspected and cited for significant quality control and equipment management deficiencies. Observations included a failure to thoroughly investigate out-of-specification results for Nitroglycerin Transdermal System and not submitting a Field Alert Report. Additionally, the firm used unmonitored and improperly maintained freezers for reference standards and failed to calibrate manufacturing equipment across its full operating range.

## Related Officers

- [Mindy M. Chou](https://www.globalkeysolutions.net/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

Company: https://www.globalkeysolutions.net/companies/hercon-pharmaceuticals-llc/fec71b58-f9ca-4d72-a14a-c02da0a17760

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