# FDA 483 - Aurolife Pharma, LLC - December 07, 2021

Source: https://www.globalkeysolutions.net/records/483/aurolife-pharma-llc/c6b0115c-7a88-4138-8337-6f7454a491c3

> FDA 483 for Aurolife Pharma, LLC on December 07, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurolife Pharma, LLC
- Inspection Date: 2021-12-07
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of AuroLife Pharma, LLC in Dayton, NJ, revealed significant deficiencies in data integrity, quality control unit procedures, and facility maintenance, including persistent water leaks. The inspection also cited inadequate laboratory controls, unvalidated test methods, and insufficient equipment cleaning protocols, indicating a broad failure to adhere to cGMP regulations. Several observations were repeats from a previous 483, highlighting a lack of effective corrective actions.

## Related Documents

- [483 - 2019-10-22](https://www.globalkeysolutions.net/records/483/aurolife-pharma-llc/5b283c99-9b47-413e-9caf-15e27bb8a8bf)
- [483 - 2020-02-12](https://www.globalkeysolutions.net/records/483/aurolife-pharma-llc/1c6eef37-2104-432a-93e6-3a687c3d4c8f)
- [WARNING_LETTER - 2020-02-12](https://www.globalkeysolutions.net/records/warning_letter/aurolife-pharma-llc/8d5386ca-53df-44f7-9289-0337abcaf29f)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/jay-b-shah/c437fff9-807e-4dea-80c0-8f77850db6f8)
- [Consumer Safety Officer at FDA U.S. Food and Drug Administration](https://www.globalkeysolutions.net/people/ko-u-min/9bb5f33e-857b-4c6f-a550-fdb439760e30)
- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.globalkeysolutions.net/companies/aurolife-pharma-llc/b82a0c8c-6b52-4624-8c6c-21887615bc7d

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