Ol Pharma Tech LLCJuly 22, 2024

FDA 483 - Ol Pharma Tech LLC - July 22, 2024

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Record Details

Ol Pharma Tech LLC received a Form 483 citing significant deficiencies across its quality system, laboratory controls, and manufacturing processes. The inspection revealed a lack of an independent quality control unit, unwritten and unapproved procedures, and inadequate testing for product stability and microbial contamination. The firm also failed to validate manufacturing processes, maintain proper batch records, and provide essential employee training.

Company: Ol Pharma Tech LLC
Inspection Date: July 22, 2024
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations III
People: Joohi Castelvetere
Nicholas J. Presto

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