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483
•Sure-Biochem Laboratories, LLC•March 8, 2024

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

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Record Details

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.

Company
Sure-Biochem Laboratories, LLC
Inspection Date
March 8, 2024
Product Type
Drugs
Office
New Jersey District Office
People
  • Christina K. Theodorou (Consumer Safety Officer)
  • Yoriann M. Cabrera Bartolomei
  • Yaharn Su
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ID · b556f895-236a-4a3f-ac9b-3170e5202c0f

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