# FDA 483 - Western Innovations, Inc. - April 30, 2025

Source: https://www.globalkeysolutions.net/records/483/western-innovations-inc/d9470ae7-0b9d-4173-a0fd-110daef725d4

> FDA 483 for Western Innovations, Inc. on April 30, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Western Innovations, Inc.
- Inspection Date: 2025-04-30
- Product Type: other
- Office Name: Denver District Office
- Summary: Western Innovations, Inc. received a Form 483 with 26 observations detailing significant deficiencies in their dietary supplement manufacturing processes. The inspection revealed a pervasive lack of established specifications for components and finished products, along with inadequate batch and master manufacturing records. Furthermore, the firm exhibited poor sanitation practices, issues with equipment maintenance and calibration, and a critical absence of essential written procedures for quality control, manufacturing, packaging, and laboratory operations.

## Related Documents

- [WARNING_LETTER - 2024-02-21](https://www.globalkeysolutions.net/records/warning_letter/western-innovations-inc/5858b00e-26aa-493a-8462-c006c91a2df3)

## Related Officers

- [Megan K. Rand](https://www.globalkeysolutions.net/people/megan-k-rand/a659b088-3726-409f-a56c-ead57611fa4f)
- [Gary C. Pecic](https://www.globalkeysolutions.net/people/gary-c-pecic/37cf1f4d-6b1c-4be6-8adb-89cf685f5022)

Company: https://www.globalkeysolutions.net/companies/western-innovations-inc/95e0efec-3e93-48e7-b3d5-b372ded76894

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face