# FDA 483 - Sure-Biochem Laboratories, LLC - March 08, 2024

Source: https://www.keypedia.com/records/483/sure-biochem-laboratories-llc/b556f895-236a-4a3f-ac9b-3170e5202c0f

> FDA 483 for Sure-Biochem Laboratories, LLC on March 08, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sure-Biochem Laboratories, LLC
- Inspection Date: 2024-03-08
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Sure-Biochem Laboratories, LLC in Camden, NJ, was issued a Form 483 following an inspection from March 4-8, 2024, for significant compliance issues. The firm failed to make records associated with drug product control readily available, specifically a three-year raw data retrospective review and a comprehensive independent assessment. These failures occurred despite prior commitments made in response to an FDA Warning Letter, indicating serious concerns regarding data integrity and quality system oversight.

## Related Documents

- [483 - 2022-10-07](https://www.keypedia.com/records/483/sure-biochem-laboratories-llc/3aef9d1e-5973-412e-a9f3-0e7b4d2e0dce)
- [WARNING_LETTER - 2022-10-07](https://www.keypedia.com/records/warning_letter/sure-biochem-laboratories-llc/f9a62d0f-0e66-450e-8e2e-1e9a1d455643)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)
- [Yoriann M. Cabrera Bartolomei](https://www.keypedia.com/people/yoriann-m-cabrera-bartolomei/3f827fbc-dcd1-4698-9bae-e0e93b900d08)
- [Yaharn Su](https://www.keypedia.com/people/yaharn-su/75b7f7fd-d853-436e-b538-386a8c6df3cb)

Company: https://www.keypedia.com/companies/sure-biochem-laboratories-llc/925d6cde-86fd-4ad8-84ce-e867eb5b48be

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