# FDA 483 - Autumn Harp - April 30, 2025

Source: https://www.globalkeysolutions.net/records/483/autumn-harp/ac0d2006-dde8-40a2-ba70-c5fb33083dd4

> FDA 483 for Autumn Harp on April 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Autumn Harp
- Inspection Date: 2025-04-30
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Autumn Harp, Inc. in Essex Junction, VT, revealed deficient component testing practices. The firm failed to adequately test all containers of Glycerin USP 99.7% for ethylene glycol/diethylene glycol impurities, despite using this component in the manufacture of SPF sunscreen drug products. This indicates a significant lapse in quality control for raw materials.

## Related Documents

- [483 - 2019-12-19](https://www.globalkeysolutions.net/records/483/autumn-harp/aefb486c-048f-4a2f-839c-3db95d7506f1)

## Related Officers

- [Armen H. Youssoufian](https://www.globalkeysolutions.net/people/armen-h-youssoufian/47aa0283-ca67-4aec-8ac1-7d4cb222eb04)

Company: https://www.globalkeysolutions.net/companies/autumn-harp/356bbe3b-137a-49c7-8679-f892a5b9bb57

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144