# FDA 483 - ECI Pharmaceuticals, LLC - January 27, 2023

Source: https://www.keypedia.com/records/483/eci-pharmaceuticals-llc/fa0ab10c-05b1-4bc7-babb-d520a10b6e49

> FDA 483 for ECI Pharmaceuticals, LLC on January 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ECI Pharmaceuticals, LLC
- Inspection Date: 2023-01-27
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: ECI Pharmaceuticals, LLC in Ft Lauderdale, FL, was inspected regarding its post-marketing adverse drug experience reporting. The inspection revealed significant deficiencies in written procedures for surveillance, evaluation, and electronic submission of adverse drug experience reports. Additionally, the firm failed to submit required annual reports and periodic adverse drug experience reports for an active NDA.

## Related Documents

- [483 - 2015-02-27](https://www.keypedia.com/records/483/eci-pharmaceuticals-llc/f89eb926-638e-4764-a121-8ef4bb77eed7)
- [483 - 2016-11-18](https://www.keypedia.com/records/483/eci-pharmaceuticals-llc/3254d621-68f4-4e29-9da4-7bcad2a3236d)
- [WARNING_LETTER - 2022-02-15](https://www.keypedia.com/records/warning_letter/eci-pharmaceuticals-llc/05b801ef-f639-4c6d-885c-52c9e876cf74)
- [WARNING_LETTER - 2022-03-22](https://www.keypedia.com/records/warning_letter/eci-pharmaceuticals-llc/ba249f39-27ff-4445-a618-e86838030f85)

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-f-duff/7efbc61c-5f7a-4d2c-86d9-500291ee6789)

Company: https://www.keypedia.com/companies/eci-pharmaceuticals-llc/82443550-cfc6-4f79-b5ee-7025247b03a8

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