# FDA 483 - Kwokcheng Enterprise, Inc. dba Fullei Fresh - July 21, 2021

Source: https://www.keypedia.com/records/483/kwokcheng-enterprise-inc-dba-fullei-fresh/10daea5e-7ed3-4b62-8439-d42e34350dd2

> FDA 483 for Kwokcheng Enterprise, Inc. dba Fullei Fresh on July 21, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kwokcheng Enterprise, Inc. dba Fullei Fresh
- Inspection Date: 2021-07-21
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Kwokcheng Enterprise, Inc. dba Fullei Fresh, a sprout manufacturer in Miami, FL, was cited for significant insanitary conditions and inadequate aseptic sampling practices during an FDA inspection. Observations included multiple instances of direct product contamination risks, poor equipment maintenance, pest issues, and a failure to ensure aseptic collection of spent irrigation water samples, with several issues being repeat observations.

## Related Documents

- [WARNING_LETTER - 2019-03-11](https://www.keypedia.com/records/warning_letter/kwokcheng-enterprise-inc-dba-fullei-fresh/82af83fb-daec-4693-af9b-d5a4a9a1d5ff)
- [483 - 2022-04-06](https://www.keypedia.com/records/483/kwokcheng-enterprise-inc-dba-fullei-fresh/5ae01205-0008-4883-841b-3e64fa5914e4)
- [483 - 2022-12-15](https://www.keypedia.com/records/483/kwokcheng-enterprise-inc-dba-fullei-fresh/8a707eb8-d729-4e31-ae06-c05795bf7b58)

## Related Officers

- [Kelsey T Witherwax, Investigator](https://www.keypedia.com/people/kelsey-t-witherwax-investigator/0e730364-62ce-41be-aa89-de58947a7170)
- [Anabel Veiga, Investigator](https://www.keypedia.com/people/anabel-veiga-investigator/13b0d4e8-a19e-4e41-8ed6-173326a26375)
- [Lissette Paiz, Investigator](https://www.keypedia.com/people/lissette-paiz-investigator/ca00f7ae-bd23-4880-ae34-90d7971fbbf4)
- [Robert J Goldman, Investigator](https://www.keypedia.com/people/robert-j-goldman-investigator/d05fec20-a9d8-4ea0-b04f-34ecd5d57fbd)
- [Jason S Auh, Investigator](https://www.keypedia.com/people/jason-s-auh-investigator/e516001a-bc41-4e31-849e-15c114be081d)

Company: https://www.keypedia.com/companies/kwokcheng-enterprise-inc-dba-fullei-fresh/f5cfe5a9-5bdb-4ab3-bdf9-ef4b4e496160

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6