# FDA 483 - Sure-Biochem Laboratories, LLC - October 07, 2022

Source: https://www.keypedia.com/records/483/sure-biochem-laboratories-llc/3aef9d1e-5973-412e-a9f3-0e7b4d2e0dce

> FDA 483 for Sure-Biochem Laboratories, LLC on October 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sure-Biochem Laboratories, LLC
- Inspection Date: 2022-10-07
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Sure-Biochem Laboratories, LLC, a contract testing laboratory in Camden, NJ, was cited for significant deficiencies during an FDA inspection. The firm lacks a functional quality control unit, operates with inadequate laboratory controls and unvalidated test methods, and consistently fails to follow its own standard operating procedures. These issues indicate a severe lack of control over testing processes for OTC drug products and environmental monitoring, raising concerns about data integrity and product quality.

## Related Documents

- [WARNING_LETTER - 2022-10-07](https://www.keypedia.com/records/warning_letter/sure-biochem-laboratories-llc/f9a62d0f-0e66-450e-8e2e-1e9a1d455643)
- [483 - 2024-03-08](https://www.keypedia.com/records/483/sure-biochem-laboratories-llc/b556f895-236a-4a3f-ac9b-3170e5202c0f)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)
- [Juanita P Vereen](https://www.keypedia.com/people/juanita-p-vereen/c1f1555f-fb27-4ea6-9cc2-57cebd741ae5)
- [Investigator](https://www.keypedia.com/people/kristina-l-conroy/d6f2d9e4-f547-4bb2-9531-157b5890fae0)

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