# FDA 483 - ARP Manufacturing, LLC - August 29, 2019

Source: https://www.keypedia.com/records/483/arp-manufacturing-llc/edad7585-f04a-4e95-8bb2-f47f0cdde6be

> FDA 483 for ARP Manufacturing, LLC on August 29, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARP Manufacturing, LLC
- Inspection Date: 2019-08-29
- Product Type: device
- Office Name: Denver District Office
- Summary: ATE Manufacturing, LLC, a medical device manufacturer in Centennial, CO, received two observations during an FDA inspection. The firm was cited for inadequate procedures regarding supplier assessment and approval, specifically concerning ongoing supplier evaluations. Additionally, the inspection found deficiencies in the control of nonconforming material, including incomplete disposition records.

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.keypedia.com/companies/arp-manufacturing-llc/3f0f5ccb-e7c3-45c2-b5c4-c345fdf79072

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