# FDA 483 - Moldworks Worldwide LLC - February 13, 2020

Source: https://www.keypedia.com/records/483/moldworks-worldwide-llc/0acfefcd-7895-4a2f-86c6-7696592370ab

> FDA 483 for Moldworks Worldwide LLC on February 13, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Moldworks Worldwide LLC
- Inspection Date: 2020-02-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Moldworks Worldwide LLC in Linden, NJ, identified a single observation related to inadequate documentation of acceptance activities. The firm failed to document measurements of finished devices to ensure conformance with Device Master Record specifications. This indicates a deficiency in their quality system for device manufacturing.

## Related Officers

- [Andrew J. Garufi](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.keypedia.com/companies/moldworks-worldwide-llc/a16982dc-7e54-4de0-95c4-48b0e95f725c

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961