# FDA 483 - Washington Homeopathic Products, Inc. - August 19, 2021

Source: https://www.globalkeysolutions.net/records/483/washington-homeopathic-products-inc/a0ce06d3-8a97-4747-9e5d-1a342cdf8fcd

> FDA 483 for Washington Homeopathic Products, Inc. on August 19, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Washington Homeopathic Products, Inc.
- Inspection Date: 2021-08-19
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Washington Homeopathic Products, Inc. in Berkeley Springs, WV, was cited for significant quality control and manufacturing deficiencies during an FDA inspection. The firm failed to conduct a timely risk assessment and recall determination for homeopathic drug products made with raw materials that failed identity testing. Additionally, the inspection revealed inadequate written procedures for production and process controls, including deficient process validation studies, and a failure to follow their written stability testing program.

## Related Documents

- [483 - 2019-07-02](https://www.globalkeysolutions.net/records/483/washington-homeopathic-products-inc/d2e20725-1487-43fd-9135-2799c7b54671)
- [WARNING_LETTER - 2019-07-02](https://www.globalkeysolutions.net/records/warning_letter/washington-homeopathic-products-inc/a42e29fb-caa9-4a06-bd62-b66aa77ef448)

## Related Officers

- [Consumer Safety Officer ](https://www.globalkeysolutions.net/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.globalkeysolutions.net/companies/washington-homeopathic-products-inc/3f742661-d83f-4a3b-a138-4b8369ad43d9

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e