Petscript Inc – FDA 483, Sep 8, 2025

Petscript Inc. received an FDA Form 483 following an inspection from September 8 to September 18, 2025, detailing significant concerns regarding their sterile and non-sterile drug product manufacturing practices. Key issues centered on a deficient quality control unit, inadequate aseptic processing, and lack of validation.

Specifically, the company lacked written procedures for quality unit responsibilities, including product release, and failed to properly review, approve, and date existing procedures. Critical deficiencies were noted in aseptic processing validation; media fills did not accurately simulate production conditions, and sterilization cycles for various drug products, as well as cleaning/sterilization processes for components like stoppers and vials, were unvalidated.

Further observations included the absence of environmental and personnel monitoring in classified sterile production areas, failure to address a leaking HEPA filter, and a lack of routine testing for sterility, endotoxin, or potency for all drug products. The firm also lacked an established stability testing program to justify Beyond Use Dates. Manual handling practices in sterile environments and unrepresentative smoke studies highlighted additional contamination risks.

These observations indicate a failure to adhere to current Good Manufacturing Practices, necessitating immediate corrective actions to ensure product quality, safety, and regulatory compliance. The company must implement robust quality systems, validate all critical processes, and establish comprehensive monitoring and testing programs.