FDA EIR - Haupt Pharma Latina Srl - June 28, 2018

A surveillance inspection by the FDA of Haupt Pharma Latina Srl in Latina, Italy, was conducted from June 21 to June 28, 2018. The inspection focused on quality, production, laboratory, and packaging and labeling systems, adhering to regulatory guidelines CPGM 7371.001 for Animal Drug Manufacturing and CPGM 7356.002A for Sterile Drug Process Inspections.The inspection resulted in an FDA Form 483 with five observations. Key issues identified included an unsanitary and poorly maintained aseptic processing suite and inadequate media fills that failed to simulate worst-case aseptic operations. Furthermore, the firm's management of Restricted Access Barrier System (RABS) gloves was deficient, lacking scientific justification for usage limits, integrity testing, and qualified operators for inspections. There was also an absence of a validated method to neutralize specific product properties and insufficient training assurance for operators performing visual inspections to detect product defects. A recurring issue involved filling veterinary pharmaceuticals into containers with known integrity problems for over eighteen months before supplier corrections were implemented.Haupt Pharma Latina's management committed to submitting a written response addressing the FDA 483 observations within 15 business days following the inspection's conclusion. The final classification of this inspection is pending evaluation by CDER.