FDA EIR - Haupt Pharma Latina Srl - August 27, 2018

An FDA surveillance inspection of Haupt Pharma Latina SrL in Latina, Italy, occurred from June 21 to June 28, 2018. This inspection focused on the firm's quality, production, laboratory, and packaging and labeling systems for human and veterinary sterile and non-sterile drug products. It was conducted in accordance with FDA's compliance program guidance for animal drug and sterile drug manufacturing. The agency identified five significant issues, leading to the issuance of an FDA Form 483, Inspectional Observations.

Key violations included the aseptic processing suite being in a dirty and disrepair state. The firm's media fills lacked worst-case scenario challenges, and procedures for isolator (RABS) glove management were inadequate, lacking scientific rationale for usage limits, integrity testing, and operator qualification. Additionally, Haupt Pharma Latina did not have a validated method to neutralize certain drug product properties and failed to ensure operators performing visual inspections were properly trained to detect critical defects like particulates or leaks. A recurring issue involved the firm filling veterinary pharmaceuticals into containers with known integrity concerns for over 1.5 years before supplier corrective measures were implemented. Management committed to providing a written response to the FDA's observations within 15 business days. The final classification of the inspection is pending further evaluation.