# FDA 483 - Kari Gran Inc. - July 08, 2022

Source: https://www.globalkeysolutions.net/records/483/kari-gran-inc/ba3dd9f8-754f-488c-b049-ca5131642879

> FDA 483 for Kari Gran Inc. on July 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kari Gran Inc.
- Inspection Date: 2022-07-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Kari Gran Inc. in Seattle, WA, was inspected by the FDA, resulting in 11 observations related to significant deficiencies in their manufacturing and quality control processes for drug products, specifically Essential SPF. The inspection revealed a lack of adequate finished product testing, insufficient investigations into product complaints, and absent or inadequate written procedures for quality control, production, process validation, annual product reviews, and stability testing. Additionally, issues were noted with batch record documentation, component testing, and product labeling.

## Related Documents

- [WARNING_LETTER - 2022-07-08](https://www.globalkeysolutions.net/records/warning_letter/kari-gran-inc/dc93f50d-1e5d-4fe0-a910-308c3669836b)

## Related Officers

- [Regulatory Affairs Specialist](https://www.globalkeysolutions.net/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [issuing_officer](https://www.globalkeysolutions.net/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

Company: https://www.globalkeysolutions.net/companies/kari-gran-inc/70f14ea9-3719-49ba-bef8-d2fc1250b8be

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822