# FDA 483 - Curexa - East, LLC dba Curexa - September 09, 2022

Source: https://www.globalkeysolutions.net/records/483/curexa-east-llc-dba-curexa/8fc76674-284a-4e67-a014-2db69ecd6178

> FDA 483 for Curexa - East, LLC dba Curexa on September 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curexa - East, LLC dba Curexa
- Inspection Date: 2022-09-09
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Curexa - East, LLC dba Curexa in Egg Harbor Township, NJ, revealed significant deficiencies in manufacturing practices. Observations included widespread non-microbial contamination in production areas, inadequate cleaning procedures for hazardous drug production leading to potential cross-contamination, and the release of drug products with inconsistent fill heights, impacting quality. These issues indicate a lack of control over the manufacturing environment and product quality.

## Related Documents

- [483 - 2018-09-27](https://www.globalkeysolutions.net/records/483/curexa-east-llc-dba-curexa/3ecdd923-c17d-45f4-b541-0f45eb974dea)
- [483 - 2018-09-27](https://www.globalkeysolutions.net/records/483/curexa-east-llc-dba-curexa/15c48e5f-5790-4537-ba73-ff7e7caf5649)
- [483 - 2020-10-09](https://www.globalkeysolutions.net/records/483/curexa-east-llc-dba-curexa/50d597f5-0829-4ee6-8d86-c3c79900bb36)
- [WARNING_LETTER - 2022-09-09](https://www.globalkeysolutions.net/records/warning_letter/curexa-east-llc-dba-curexa/6aabcedc-38a8-4124-8d2e-e9271b79002d)

## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)
- [Sena G. Dissmeyer](https://www.globalkeysolutions.net/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)

Company: https://www.globalkeysolutions.net/companies/curexa-east-llc-dba-curexa/0497cfad-c674-4485-9b11-13ede03b0cfd

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