# FDA 483 - E5 Pharma LLC - February 17, 2023

Source: https://www.globalkeysolutions.net/records/483/e5-pharma-llc/9b793e24-b3c2-4256-8442-83052999658b

> FDA 483 for E5 Pharma LLC on February 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: E5 Pharma LLC
- Inspection Date: 2023-02-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: E5 Pharma LLC, a labeler/relabeler in Boca Raton, FL, was cited for significant deficiencies in its pharmacovigilance system. The firm failed to report an adverse drug experience within the required timeframe and submitted incomplete periodic reports. Additionally, the company lacked adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/sheri-l-stephenson/dd4f3755-bb3b-4a14-a08f-8d59fbb0b6fa)

Company: https://www.globalkeysolutions.net/companies/e5-pharma-llc/cec53ef3-d0b7-4aff-9bf0-1b1c8325e302

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6