# FDA 483 - Kwokcheng Enterprise, Inc. dba Fullei Fresh - April 06, 2022

Source: https://www.keypedia.com/records/483/kwokcheng-enterprise-inc-dba-fullei-fresh/5ae01205-0008-4883-841b-3e64fa5914e4

> FDA 483 for Kwokcheng Enterprise, Inc. dba Fullei Fresh on April 06, 2022. 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: 2022-04-06
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Kwokcheng Enterprise, Inc. dba Fullei Fresh, a sprout grower in Miami, FL, revealed severe and repeat violations related to sanitation, hygienic practices, and equipment maintenance. Environmental samples showed widespread Listeria monocytogenes contamination on surfaces, including repeat positives from previous inspections. The firm also failed to aseptically collect samples and released sprouts into commerce without confirmed negative pathogen test results, posing a significant risk of contamination.

## 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 - 2021-07-21](https://www.keypedia.com/records/483/kwokcheng-enterprise-inc-dba-fullei-fresh/10daea5e-7ed3-4b62-8439-d42e34350dd2)
- [483 - 2022-12-15](https://www.keypedia.com/records/483/kwokcheng-enterprise-inc-dba-fullei-fresh/8a707eb8-d729-4e31-ae06-c05795bf7b58)

## Related Officers

- [Andrew J. Mcguffin](https://www.keypedia.com/people/andrew-j-mcguffin/1cb78859-f87a-4dc7-bb3c-b6440ca04e40)
- [Edwards Carbonell](https://www.keypedia.com/people/edwards-carbonell/304f561b-f953-4ebb-acce-b928ed0bb986)
- [investigator](https://www.keypedia.com/people/lissette-paiz/3d6c9613-59f6-4998-996a-93500997140f)
- [Karissa J. Mccaw](https://www.keypedia.com/people/karissa-j-mccaw/46918355-1497-4799-b6e3-cc2e3c917d9d)
- [investigator](https://www.keypedia.com/people/emily-a-green/99d6d052-ed5c-4d09-9fad-f0d2b740725f)

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