# FDA 483 - Bulletproof 360 Inc - September 06, 2019

Source: https://www.globalkeysolutions.net/records/483/bulletproof-360-inc/924175e7-ab13-4c79-a934-0386068ab3c8

> FDA 483 for Bulletproof 360 Inc on September 06, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bulletproof 360 Inc
- Inspection Date: 2019-09-06
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Bulletproof 360 Inc. in Seattle, WA, an own label distributor of dietary supplements and conventional food, was cited for significant quality control failures. The inspection revealed a lack of established specifications for both raw materials and finished products, a failure to properly investigate numerous serious adverse event and adverse reaction complaints, and inadequate production and process controls, including issues with contract manufacturer qualification and allergen control. Furthermore, the firm lacked a proper supply-chain program, highlighted by a Class I recall for Listeria contamination in protein bars and a mislabeled dietary supplement recall.

## Related Documents

- [WARNING_LETTER - 2019-09-06](https://www.globalkeysolutions.net/records/warning_letter/bulletproof-360-inc/be505063-46fb-4630-8155-08d761ec1b85)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/jinkee-m-vila-binayug/f179a155-6e1d-4c80-a4ac-917d15b438fe)

Company: https://www.globalkeysolutions.net/companies/bulletproof-360-inc/77e542cf-be1d-4cb6-8460-752e94624459

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822