# FDA 483 - Setton International Foods, Inc. - April 08, 2009

Source: https://www.keypedia.com/records/483/setton-international-foods-inc/4f463506-76b2-4900-898f-010fee4ebf06

> FDA 483 for Setton International Foods, Inc. on April 08, 2009. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Setton International Foods, Inc.
- Inspection Date: 2009-04-08
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: From March 31 to April 8, 2009, the FDA inspected Setton International Foods, Inc., a manufacturer and repacker located at 85 Austin Blvd, Commack, NY. The inspection revealed six observations regarding sanitation and hygiene practices.

Observation 1 noted a failure to conduct cleaning and sanitizing operations to protect against food contamination. The firm's "Equipment Cleaning Procedures" SOP was inadequate, only calling for sanitization without a prior wash step. Employees were observed performing only a sanitization step, and the "Master Cleaning Schedule Log" did not include all items from the SOP. Additionally, the firm lacked sanitizer test strips to verify chlorine solution concentration.

Observation 3 detailed employees failing to wash hands thoroughly when soiled or contaminated. An employee was seen handling a box cutter, then returning to packing ready-to-eat sour bears without changing gloves or washing hands. Two employees touched food-contact surfaces of lids.

Observation 4 highlighted a lack of adequate handwashing facilities. The only sinks were in employee bathrooms, with none in the Packaging, Panning, Organic, or Roasting Rooms where ready-to-eat foods are processed.

Observation 5 cited a failure to wear appropriate hair restraints. Employees and a manager with facial hair were observed in processing areas without restraints. Hairnets were also worn ineffectively, not covering all hair.

Finally, Observation 6 noted a failure to provide safety-type lighting fixtures over exposed food,

## Related Documents

- [483 - 2009-04-08](https://www.keypedia.com/records/483/setton-international-foods-inc/ed9e820f-269f-4e05-a88a-0e4147ad73f8)
- [483 - 2009-04-08](https://www.keypedia.com/records/483/setton-international-foods-inc/08877a3f-ae2b-49b1-bb18-fa4dff99eb9d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/jane-chen/4f0b3c6c-44e9-4db4-a140-4c1d5761ee55)
- [Sarah A. Wangseng](https://www.keypedia.com/people/sarah-a-wangseng/9a76d2f7-0dd8-42ad-8362-f0bbd1e761a5)
- [Investigator](https://www.keypedia.com/people/frank-verni/a72274c0-026a-4ca1-8829-d578745f04c0)
- [Director](https://www.keypedia.com/people/matthew-r-palo/e0c69866-bad8-4694-bfd3-65713495250b)

Company: https://www.keypedia.com/companies/setton-international-foods-inc/278a6b54-7959-44fe-a695-0438f84256e8

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c