# FDA WARNING_LETTER - Good Seed, Inc. - June 03, 2015

Source: https://www.keypedia.com/records/warning_letter/good-seed-inc/5181a421-b7a4-4e4b-b8ae-a6c5463049fd

> FDA WARNING_LETTER for Good Seed, Inc. on June 03, 2015. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Good Seed, Inc.
- Inspection Date: 2015-06-03
- Product Type: Food
- Office Name: Baltimore District Office
- Summary: The FDA inspected Good Seed, Inc.'s sprout facility from June 1-3, 2015, and found serious violations. Environmental samples tested positive for *Listeria monocytogenes* on a food-contact surface of a sprout bagging machine. This strain matched *Listeria* found in Virginia Department of Agriculture and Consumer Services (VDACS) product samples. This indicates inadequate sanitation and adulterated food products under 21 U.S.C. § 342(a)(4).

Good Seed, Inc. failed to report three voluntary recalls of soybean and mung bean sprouts due to *Listeria* contamination to the Reportable Food Registry (RFR) within 24 hours, a violation of 21 U.S.C. § 350f(d)(1) and a prohibited act under 21 U.S.C. § 331(mm).

Additionally, the inspection revealed a Current Good Manufacturing Practice (CGMP) violation (21 CFR 110.35(d)) for failing to adequately clean food-contact surfaces. Food particles were observed on a bagging machine's hopper and conveyor belt, which had been cleaned the previous day, directly where the *Listeria* positive sample was collected.

The firm's June 15, 2015, response to the FDA Form 483 was deemed insufficient as it lacked specific details on

## Related Documents

- [WARNING_LETTER - 2015-06-03](https://www.keypedia.com/records/warning_letter/good-seed-inc/c8346f17-9641-4f15-9852-0dacda75b511)

## Related Officers

- [District Director](https://www.keypedia.com/people/evelyn-bonnin/3fdb9ef8-ea23-4a86-9176-cab37e5dea36)

Company: https://www.keypedia.com/companies/good-seed-inc/43e8500a-efd8-4bcd-8be6-75678143fad3

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa