# FDA 483 - VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products - April 17, 2015

Source: https://www.globalkeysolutions.net/records/483/vitasea-products-intl-inc-dba-wachters-organic-sea-products/600b95d5-e538-40fa-a462-b7ce2a3d313e

> FDA 483 for VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products on April 17, 2015. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: VitaSea Products Int'l , Inc. dba Wachters' Organic Sea Products
- Inspection Date: 2015-04-17
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of VitaSea Products Int'l, dba Wachters Organic Sea Products in Daly City, CA, revealed numerous deficiencies in their dietary supplement manufacturing processes. The firm lacked essential written procedures for quality control, cleaning, and sampling, and failed to establish specifications for manufacturing stages. Additionally, observations noted inadequate contamination controls and deviations from master manufacturing records, indicating a severe lack of adherence to good manufacturing practices.

## Related Documents

- [483 - 2017-06-19](https://www.globalkeysolutions.net/records/483/vitasea-products-intl-inc-dba-wachters-organic-sea-products/b6246612-fef7-4838-a18b-dadda6efd6b6)
- [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

- [Kristin M. Abaonza](https://www.globalkeysolutions.net/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)
- [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