# FDA 483 - VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products - June 19, 2017

Source: https://www.globalkeysolutions.net/records/483/vitasea-products-intl-inc-dba-wachters-organic-sea-products/b6246612-fef7-4838-a18b-dadda6efd6b6

> FDA 483 for VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products on June 19, 2017. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products
- Inspection Date: 2017-06-19
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Vit-sea Products Int'l, dba Wachters Organic Sea Products in Daly City, CA, a dietary supplement manufacturer, revealed four significant deficiencies. The firm failed to establish specifications, written quality control procedures, and adequate master manufacturing records. All observations were repeat citations from a previous Warning Letter, indicating a serious and unaddressed lack of compliance with manufacturing regulations.

## Related Documents

- [483 - 2015-04-17](https://www.globalkeysolutions.net/records/483/vitasea-products-intl-inc-dba-wachters-organic-sea-products/600b95d5-e538-40fa-a462-b7ce2a3d313e)
- [483 - 2018-07-19](https://www.globalkeysolutions.net/records/483/vitasea-products-intl-inc-dba-wachters-organic-sea-products/c190c359-d131-4943-8aa6-d609b440ae81)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/nympha-v-florendo/3f9aa233-fb1c-417d-9c1d-24bbbd070f29)

Company: https://www.globalkeysolutions.net/companies/vitasea-products-intl-inc-dba-wachters-organic-sea-products/1cf3444b-a25d-4908-ba75-144646cb3dbf

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b