# FDA 483 - Higley Industries, Inc. - September 12, 2025

Source: https://www.globalkeysolutions.net/records/483/higley-industries-inc/b777659a-5afd-48af-9c8d-9a1731e33a25

> FDA 483 for Higley Industries, Inc. on September 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Higley Industries, Inc.
- Inspection Date: 2025-09-12
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: Higley Industries, Inc. in Dyersville, IA, a human drug manufacturer, was cited for significant deficiencies across its quality control, production, and record-keeping systems. Repeat observations highlight failures in raw material identity testing, inadequate quality unit oversight, and insufficient investigation of discrepancies. The inspection revealed a systemic lack of adherence to cGMP requirements, impacting product quality and control.

## Related Documents

- [483 - 2023-09-21](https://www.globalkeysolutions.net/records/483/higley-industries-inc/e763d22a-7072-40fe-9f96-a6e90de71b2c)
- [WARNING_LETTER - 2023-09-21](https://www.globalkeysolutions.net/records/warning_letter/higley-industries-inc/38d5e5a7-3215-4bcc-9659-ef3bd8ad9024)

## Related Officers

- [Monica E. Murie](https://www.globalkeysolutions.net/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)

Company: https://www.globalkeysolutions.net/companies/higley-industries-inc/b2aedcac-ab40-4e5b-9fc4-6c35e67098cb

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79