FDA 483 - Perla del Pacifico, S.R.L. - June 27, 2018

An FDA inspection of Perla del Pacifico, S.R.L., a seafood/LACF manufacturer in Tacna, Peru, revealed significant deficiencies across multiple areas. The firm's HACCP plans were inadequate, critical processing records were incomplete or not contemporaneously recorded, and personnel lacked required thermal processing training. Additionally, sanitation conditions and practices were found to be deficient, indicating a broad failure to adhere to good manufacturing practices.