FDA EIR - Latina Pharma S.p.A. - September 27, 2019

An FDA surveillance inspection of Corden Pharma Latina S.p.A., a sterile Active Pharmaceutical Ingredient (API) and sterile/non-sterile finished dosage contract manufacturer located in Sermoneta, Italy, was conducted from September 16 to September 27, 2019. This inspection followed regulatory guidelines for API process, sterile drug, and general drug manufacturing. The visit also reviewed voluntary corrective actions from a previous 2017 inspection and an earlier Warning Letter.

While the firm's previous corrective actions were found adequate, the current inspection identified several deficiencies, leading to a Form FDA 483 with three observations. Key issues included a lack of environmental monitoring data for production tools in direct contact with sterile API, improper execution of a microbial testing method that could produce false negative results, and incomplete microbiology records missing media lot numbers and expiration dates. These record-keeping omissions could impede thorough investigations into out-of-specification or out-of-trend microbial findings.

The company's Managing Director committed to implementing voluntary corrective actions and submitting a written response to the FDA 483 within approximately 15 working days. The inspection was classified as Voluntary Actions Indicated (VAI), meaning corrective measures are required, and a re-inspection will be scheduled as deemed necessary.