# FDA 483 - Globus Medical, Inc. - September 27, 2019

Source: https://www.keypedia.com/records/483/globus-medical-inc/032e4f3e-c342-45f8-ac8b-fa15c60feb9b

> FDA 483 for Globus Medical, Inc. on September 27, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Globus Medical, Inc.
- Inspection Date: 2019-09-27
- Product Type: other
- Office Name: Philadelphia District Office
- Summary: Globus Medical, Inc. in Audubon, PA, was inspected by the FDA, resulting in seven observations. The inspection revealed significant issues with record-keeping and documentation for HCT/P distribution, including unrecorded storage temperatures. Additionally, the firm had inadequate procedures for controlling nonconforming products, establishing corrective and preventive actions, ensuring personnel training, and maintaining document control.

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## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/suzanne-m-healy/a4159f42-8968-4dec-89e3-46a5412bc47a)
- [Nikisha Rolden](https://www.keypedia.com/people/nikisha-rolden/ccd5f87b-fb28-493d-b0a5-2ebde50461be)

Company: https://www.keypedia.com/companies/globus-medical-inc/28189b72-9de1-4074-9971-5eeb3e956f43

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8