# FDA 483 - ECI Pharmaceuticals, LLC - November 18, 2016

Source: https://www.keypedia.com/records/483/eci-pharmaceuticals-llc/3254d621-68f4-4e29-9da4-7bcad2a3236d

> FDA 483 for ECI Pharmaceuticals, LLC on November 18, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ECI Pharmaceuticals, LLC
- Inspection Date: 2016-11-18
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: BCT Pharmaceuticals LLC, a prescription drug manufacturer in Ft Lauderdale, FL, was cited for six observations during an FDA inspection. The findings indicate significant deficiencies across production, facilities, equipment, and laboratory control systems, including inadequate in-process controls, poorly designed and maintained equipment, insufficient cleaning procedures, and a lack of environmental controls to prevent cross-contamination, exacerbated by ongoing construction. Additionally, the firm exhibited poor contemporaneous documentation practices in the laboratory.

## Related Documents

- [483 - 2015-02-27](https://www.keypedia.com/records/483/eci-pharmaceuticals-llc/f89eb926-638e-4764-a121-8ef4bb77eed7)
- [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)
- [483 - 2023-01-27](https://www.keypedia.com/records/483/eci-pharmaceuticals-llc/fa0ab10c-05b1-4bc7-babb-d520a10b6e49)

## Related Officers

- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)
- [Ileana Barreto-Petit](https://www.keypedia.com/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

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