# FDA 483 - Globe Scientific LLC - October 11, 2022

Source: https://www.keypedia.com/records/483/globe-scientific-llc/de3911ff-07f8-40aa-94b2-a2caf1ef986f

> FDA 483 for Globe Scientific LLC on October 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Globe Scientific LLC
- Inspection Date: 2022-10-11
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Globe Scientific LLC, a repackager/relabeler in Mahwah, NJ, received a Form FDA 483 with seven observations during an inspection from October 4-11, 2022. The observations primarily highlight significant deficiencies in their quality system, including a lack of established procedures for corrective and preventive actions, nonconforming product control, device history records, and medical device reporting. The firm also failed to adequately investigate customer complaints and appoint a management representative for quality system oversight.

## Related Officers

- [Colin E. Tack](https://www.keypedia.com/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.keypedia.com/companies/globe-scientific-llc/037fac10-83a4-4b5b-a196-e36e79526980

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248