# FDA 483 - Raining Rose, Inc. - January 24, 2020

Source: https://www.keypedia.com/records/483/raining-rose-inc/da74eaea-81ed-495c-853c-1d4bca193ee8

> FDA 483 for Raining Rose, Inc. on January 24, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Raining Rose, Inc.
- Inspection Date: 2020-01-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Raining Rose Inc, an OTC drug manufacturer in Cedar Rapids, IA, revealed significant deficiencies in quality control. The firm failed to perform identity testing on drug product components, lacked restricted access to labeling materials, and did not adequately clean manufacturing equipment and utensils. These issues indicate a lack of control over product safety, identity, strength, quality, and purity.

## Related Documents

- [483 - 2025-02-07](https://www.keypedia.com/records/483/raining-rose-inc/36951c5d-e098-49a5-96d6-b55c42ff1772)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/raining-rose-inc/1890de61-010a-476c-a6f8-a5dcba6625df

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8