# FDA 483 - Autumn Harp - December 19, 2019

Source: https://www.globalkeysolutions.net/records/483/autumn-harp/aefb486c-048f-4a2f-839c-3db95d7506f1

> FDA 483 for Autumn Harp on December 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Autumn Harp
- Inspection Date: 2019-12-19
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Autumn Harp in Essex Junction, VT, a drug manufacturer, revealed significant deficiencies in laboratory control mechanisms, equipment maintenance, and record-keeping. Observations included failure to follow OOS investigation procedures, lack of instrument calibration checks after repair, shared user logins without audit trails, and unsanitary conditions in a raw material sampling booth. These issues indicate a lack of adequate controls to ensure the quality and purity of OTC topical drug products.

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- [483 - 2025-04-30](https://www.globalkeysolutions.net/records/483/autumn-harp/ac0d2006-dde8-40a2-ba70-c5fb33083dd4)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7