# FDA 483 - Yusef Manufacturing Laboratories, LLC - November 04, 2022

Source: https://www.keypedia.com/records/483/yusef-manufacturing-laboratories-llc/cc672d4f-ae1d-4f65-9ae4-62eb65e32415

> FDA 483 for Yusef Manufacturing Laboratories, LLC on November 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yusef Manufacturing Laboratories, LLC
- Inspection Date: 2022-11-04
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Yusef Manufacturing Laboratories, LLC in Clearfield, UT, an OTC drug manufacturer, revealed 12 significant deficiencies across multiple systems. The firm failed to adhere to GMP regulations, including inadequate stability testing, unvalidated test methods, poor investigation of out-of-specification results, and insufficient cleaning procedures. These issues indicate a broad lack of control over the quality and purity of their hand sanitizers, SPF lotions, and SPF lip balms.

## Related Documents

- [483 - 2016-05-26](https://www.keypedia.com/records/483/yusef-manufacturing-laboratories-llc/0b8a14c7-12a1-4893-8a0d-c5811e5ec4e3)
- [483 - 2019-09-13](https://www.keypedia.com/records/483/yusef-manufacturing-laboratories-llc/36722c46-4616-4fd6-904a-718bd55c2753)
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- [WARNING_LETTER - 2021-09-24](https://www.keypedia.com/records/warning_letter/yusef-manufacturing-laboratories-llc/69895fef-af1c-42b3-803d-9eda24f47e48)

## Related Officers

- [Investigator](https://www.keypedia.com/people/lisa-shin/13c87687-fe3d-41a5-8973-42be901a5b0c)
- [Consumer Safety Officer (Drug Specialist)](https://www.keypedia.com/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)
- [Regulatory Affairs Specialist](https://www.keypedia.com/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)

Company: https://www.keypedia.com/companies/yusef-manufacturing-laboratories-llc/8339fa4e-006b-4a20-8d96-44e2b90f8992

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