# FDA 483 - Pharmachem Laboratories LLC - March 15, 2022

Source: https://www.keypedia.com/records/483/pharmachem-laboratories-llc/b3efac0c-acdd-44d2-ae5a-586d51d696a7

> FDA 483 for Pharmachem Laboratories LLC on March 15, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmachem Laboratories LLC
- Inspection Date: 2022-03-15
- Product Type: other
- Office Name: Denver District Office
- Summary: Pharmachem Laboratories in Ogden, UT, a dietary supplement manufacturer, received a Form 483 citing significant deficiencies in quality control and manufacturing processes. Observations included failures to establish identity specifications for components and finished products, lack of approved documentation for specification compliance, and inadequate controls for electronic records. These issues indicate a systemic breakdown in ensuring product quality and regulatory adherence.

## Related Officers

- [investigator](https://www.keypedia.com/people/jennifer-m-pouget/dd11e6a3-3fa7-4abd-a2ec-e6f6216d7469)
- [Matthew A. Johnson](https://www.keypedia.com/people/matthew-a-johnson/e94e2d6a-1705-4ba4-b777-d514970e5371)

Company: https://www.keypedia.com/companies/pharmachem-laboratories-llc/98b6ac5f-ec07-4583-bee5-0d9cd353f958

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