# FDA 483 - SnugZ USA, Inc. - September 17, 2021

Source: https://www.keypedia.com/records/483/snugz-usa-inc/f76a2c97-8515-44e6-842d-e555c89ee9f7

> FDA 483 for SnugZ USA, Inc. on September 17, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SnugZ USA, Inc.
- Inspection Date: 2021-09-17
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of SnugZ USA, Inc. in West Jordan, UT, an OTC drug manufacturer, revealed numerous significant deficiencies across its manufacturing and quality control operations. The firm failed to establish adequate laboratory controls, process validation, complaint handling, and environmental monitoring, indicating a systemic lack of adherence to good manufacturing practices. These issues raise concerns about the identity, strength, quality, and purity of their SPF Lip Balm, SPF Sunscreen, and Hand Sanitizer OTC products.

## Related Documents

- [483 - 2018-11-30](https://www.keypedia.com/records/483/snugz-usa-inc/603bd313-fc58-453f-96d5-6d9e5207eb43)
- [WARNING_LETTER - 2018-11-30](https://www.keypedia.com/records/warning_letter/snugz-usa-inc/8604b4dd-c24b-4876-a126-20a8509faaaa)

## Related Officers

- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)
- [Investigator](https://www.keypedia.com/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.keypedia.com/companies/snugz-usa-inc/02f0ce53-8853-4f45-9ab3-87b0fb3d50f4

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face